I 

108TH CONGRESS 

1ST SESSION H. R. 663

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

improvement of patient safety and to reduce the incidence of events 

that adversely affect patient safety, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 11, 2003

Mr. BILIRAKIS (for himself, Mr. BROWN of Ohio, Mr. TAUZIN, Mr. DINGELL, 

Mr. BARTON of Texas, Mr. WAXMAN, Mr. UPTON, Mr. MARKEY, Mr. 

GREENWOOD, Mr. TOWNS, Mr. BURR, Mr. PALLONE, Mr. WHITFIELD, 

Mr. GORDON, Mr. NORWOOD, Mr. DEUTSCH, Mr. TERRY, Mr. RUSH, Mr. 

ROGERS of Michigan, Mr. ENGEL, Mr. WYNN, Ms. MCCARTHY of Missouri, Mr. STRICKLAND, Mrs. CAPPS, Mr. JOHN, and Ms. HARMAN) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL

To amend title IX of the Public Health Service Act to 

provide for the improvement of patient safety and to 

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

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

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Patient Safety and 

5 Quality Improvement Act’’. 
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1 SEC. 2. FINDINGS AND PURPOSES. 

2 (a) FINDINGS.—The Congress finds as follows: 

3 (1) In 1999, the Institute of Medicine released 

4 a report entitled ‘‘To Err Is Human’’ that described 

5 medical errors as the 8th leading cause of death in 

6 the United States, with as many as 98,000 people 

7 dying as a result of medical errors each year. 

8 (2) To address these deaths and injuries due to 

9 medical errors, the health care system must identify 

10 and learn from such errors so that systems of care 

11 can be improved. 

12 (3) Myriad public and private patient safety ini13 tiatives have begun. The Quality Interagency Coordi14 nation Task Force has recommended steps to im15 prove patient safety that may be taken by each Fed16 eral agency involved in health care and activities re17 lating to these steps are ongoing. 

18 (4) The Department of Health and Human 

19 Services has initiated several patient safety projects. 

20 The Joint Commission on Accreditation of 

21 Healthcare Organizations issued a patient safety 

22 standard that went into effect on July 1, 2001, and 

23 the peer review organizations are conducting ongoing 

24 studies of clinical performance measurement of care 

25 delivered to beneficiaries under the medicare pro26 gram under title XVIII of the Social Security Act. 
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1 (5) Several steps can be taken now to improve 

2 patient safety. For example, according to the Cen3 ters for Disease Control and Prevention, hand wash4 ing is the single most important means of preventing 

5 the spread of infection. Repeated studies indicate 

6 that lack of or improper hand washing still contrib7 utes significantly to disease transmission in health 

8 care settings. Working with experts from the private 

9 sector, the Centers for Disease Control and Preven10 tion has drafted ‘‘Guidelines for Hand Hygiene in 

11 Healthcare Settings’’ setting forth recommendations 

12 to promote improved hand hygiene practices and re13 duce transmission of pathogenic microorganisms to 

14 patients and personnel in health care settings. 

15 (6) According to the Centers for Disease Con16 trol and Prevention, nosocomial infections affect ap17 proximately 2 million patients annually in acute care 

18 facilities in the United States at an estimated direct 

19 patient care cost of approximately $3.5 billion each 

20 year. 

21 (7) The Congress encourages the continuation 

22 and acceleration of private sector efforts to take im23 mediate steps to improve patient safety and recog24 nizes the need for action in the public sector to com25 plement these efforts. 
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1 (8) The research on patient safety unequivo2 cally calls for a learning environment, where pro3 viders will feel safe to report health care errors, in 

4 order to improve patient safety. 

5 (9) Voluntary data gathering systems are more 

6 supportive than mandatory systems in creating the 

7 learning environment referred to in paragraph (8) as 

8 stated in the Institute of Medicine’s report. 

9 (10) Promising patient safety reporting systems 

10 have been established throughout the United States, 

11 and the best ways to structure and use these sys12 tems are currently being determined, largely through 

13 projects funded by the Agency for Healthcare Re14 search and Quality. 

15 (11) Many organizations currently collecting 

16 patient safety information have expressed a need for 

17 protections that will allow them to review protected 

18 information so that they may collaborate in the de19 velopment and implementation of patient safety im20 provement strategies. Currently, the State peer re21 view protections provide inadequate conditions to 

22 allow the sharing of information to promote patient 

23 safety. 

24 (12) In 2001, the Institute of Medicine released 

25 a report entitled ‘‘Crossing the Quality Chasm’’ that 
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1 found that the United States health care system 

2 does not consistently deliver high-quality care to pa3 tients. 

4 (b) PURPOSES.—The purposes of this Act are—

5 (1) to encourage a culture of safety and quality 

6 in the United States health care system by providing 

7 for a health care errors reporting system that both 

8 protects information and improves patient safety 

9 and quality of health care; and 

10 (2) to ensure accountability by raising stand11 ards and expectations for continuous quality im12 provements in patient safety through the actions of 

13 the Secretary of Health and Human Services. 

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

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

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

17 (1) in section 912(c), by inserting ‘‘, in accord18 ance with part C,’’ after ‘‘The Director shall’’; 

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

20 (3) by redesignating sections 921 through 928, 

21 as sections 931 through 938, respectively; 

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

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

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

2 ‘‘SEC. 921. DEFINITIONS. 

3 ‘‘In this part: 

4 ‘‘(1) IDENTIFIABLE INFORMATION.—The term 

5 ‘identifiable information’ means information that is 

6 presented in a form and manner that allows the 

7 identification of any provider, patient, or reporter of 

8 patient safety work product. With respect to pa9 tients, such information includes any individually 

10 identifiable health information as that term is de11 fined in the regulations promulgated pursuant to 

12 section 264(c) of the Health Insurance Portability 

13 and Accountability Act of 1996 (Public Law 104–

14 191; 110 Stat. 2033). 

15 ‘‘(2) NONIDENTIFIABLE INFORMATION.—The 

16 term ‘nonidentifiable information’ means informa17 tion that is presented in a form and manner that 

18 prevents the identification of any provider, patient, 

19 or reporter of patient safety work product. With re20 spect to patients, such information must be de-iden21 tified consistent with the regulations promulgated 

22 pursuant to section 264(c) of the Health Insurance 

23 Portability and Accountability Act of 1996 (Public 

24 Law 104–191; 110 Stat. 2033). 

25 ‘‘(3) PATIENT SAFETY EVALUATION SYSTEM.—

26 The term ‘patient safety evaluation system’ means a 
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1 process that involves the collection, management, or 

2 analysis of information for submission to or by a pa3 tient safety organization. 

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

5 term ‘patient safety organization’ means a private or 

6 public organization or component thereof that is cer7 tified, through a process to be determined by the 

8 Secretary under section 925, to perform each of the 

9 following activities: 

10 ‘‘(A) The conduct, as the organization or 

11 component’s primary activity, of efforts to im12 prove patient safety and the quality of health 

13 care delivery. 

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

15 safety work product that is submitted by pro16 viders. 

17 ‘‘(C) The development and dissemination 

18 of evidence-based information to providers with 

19 respect to improving patient safety, such as rec20 ommendations, protocols, or information re21 garding best practices. 

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

23 product to carry out activities limited to those 

24 described under this paragraph and for the pur25 poses of encouraging a culture of safety and of 
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1 providing direct feedback and assistance to pro2 viders to effectively minimize patient risk. 

3 ‘‘(E) The maintenance of confidentiality 

4 with respect to identifiable information. 

5 ‘‘(F) The provision of appropriate security 

6 measures with respect to patient safety work 

7 product. 

8 ‘‘(G) The submission of nonidentifiable in9 formation to the Agency consistent with stand10 ards established by the Secretary under section 

11 923(b) for any National Patient Safety Data12 base. 

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

14 ‘‘(A) The term ‘patient safety work prod15 uct’ means any document or communication 

16 (including any information, report, record, 

17 memorandum, analysis, deliberative work, state18 ment, or root cause analysis) that—

19 ‘‘(i) except as provided in subpara20 graph (B), is developed by a provider for 

21 the purpose of reporting to a patient safety 

22 organization, and is reported to a patient 

23 safety organization; 

24 ‘‘(ii) is created by a patient safety or25 ganization; or 
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1 ‘‘(iii) would reveal the deliberations or 

2 analytic process of a patient safety evalua3 tion system (as defined in paragraph (3)). 

4 ‘‘(B)(i) Patient safety work product de5 scribed in subparagraph (A)(i)—

6 ‘‘(I) does not include any separate in7 formation described in clause (ii); and 

8 ‘‘(II) shall not be construed to include 

9 such separate information merely by rea10 son of inclusion of a copy of the document 

11 or communication involved in a submission 

12 to, or the fact of submission of such a copy 

13 to, a patient safety organization. 

14 ‘‘(ii) Separate information described in this 

15 clause is a document or communication (includ16 ing a patient’s medical record or any other pa17 tient or hospital record) that is developed or 

18 maintained, or exists, separately from any pa19 tient safety evaluation system. 

20 ‘‘(C) Information available from sources 

21 other than a patient safety work product under 

22 this section may be discovered or admitted in a 

23 civil or administrative proceeding, if discover24 able or admissible under applicable law. 

25 ‘‘(6) PROVIDER.—The term ‘provider’ means—
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1 ‘‘(A) an individual or entity licensed or 

2 otherwise authorized under State law to provide 

3 health care services, including—

4 ‘‘(i) a hospital, nursing facility, com5 prehensive outpatient rehabilitation facil6 ity, home health agency, and hospice pro7 gram; 

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

9 nurse practitioner, clinical nurse specialist, 

10 certified nurse midwife, psychologist, cer11 tified social worker, registered dietitian or 

12 nutrition professional, physical or occupa13 tional therapist, or other individual health 

14 care practitioner; 

15 ‘‘(iii) a pharmacist; and 

16 ‘‘(iv) a renal dialysis facility, ambula17 tory surgical center, pharmacy, physician 

18 or health care practitioner’s office, long19 term care facility, behavioral health resi20 dential treatment facility, clinical labora21 tory, or community health center; or 

22 ‘‘(B) any other person or entity specified 

23 in regulations by the Secretary after public no24 tice and comment.
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1 ‘‘SEC. 922. PRIVILEGE FOR PATIENT SAFETY WORK PROD2 UCT. 

3 ‘‘(a) PRIVILEGE.—Notwithstanding any other provi4 sion of law and subject to subsection (c), patient safety 

5 work product shall not be—

6 ‘‘(1) subject to a civil or administrative sub7 poena or order; 

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

9 civil or administrative proceeding; 

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

11 552 of title 5, United States Code (commonly known 

12 as the Freedom of Information Act), or any other 

13 similar Federal or State law; 

14 ‘‘(4) required to be admitted as evidence or oth15 erwise disclosed in any State or Federal civil or ad16 ministrative proceeding; or 

17 ‘‘(5) if the patient safety work product is identi18 fiable information and is received by a national ac19 creditation organization in its capacity as a patient 

20 safety organization—

21 ‘‘(A) used by a national accreditation orga22 nization in an accreditation action against the 

23 provider that reported the information; 

24 ‘‘(B) shared by such organization with its 

25 survey team; or 
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1 ‘‘(C) required as a condition of accredita2 tion by a national accreditation association. 

3 ‘‘(b) REPORTER PROTECTION.—

4 ‘‘(1) IN GENERAL.—A provider may not use 

5 against an individual in an adverse employment ac6 tion described in paragraph (2) the fact that the in7 dividual in good faith reported information—

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

9 having the information reported to a patient 

10 safety organization; or 

11 ‘‘(B) directly to a patient safety organiza12 tion. 

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

14 purposes of this subsection, an ‘adverse employment 

15 action’ includes—

16 ‘‘(A) the failure to promote an individual 

17 or provide any other employment-related benefit 

18 for which the individual would otherwise be eli19 gible; 

20 ‘‘(B) an adverse evaluation or decision 

21 made in relation to accreditation, certification, 

22 credentialing, or licensing of the individual; and 

23 ‘‘(C) a personnel action that is adverse to 

24 the individual concerned. 
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1 ‘‘(3) REMEDIES.—Any provider that violates 

2 this subsection shall be subject to a civil monetary 

3 penalty of not more than $20,000 for each such vio4 lation involved. Such penalty shall be imposed and 

5 collected in the same manner as civil money pen6 alties under subsection (a) of section 1128A of the 

7 Social Security Act are imposed and collected. 

8 ‘‘(c) DISCLOSURES.—Nothing in this section pro9 hibits any of the following disclosures: 

10 ‘‘(1) Voluntary disclosure of nonidentifiable in11 formation. 

12 ‘‘(2) Voluntary disclosure of identifiable infor13 mation by a provider or patient safety organization, 

14 if such disclosure—

15 ‘‘(A) is authorized by the provider for the 

16 purposes of improving quality and safety; 

17 ‘‘(B) is to an entity or person subject to 

18 the requirements of section 264(c) of the 

19 Health Insurance Portability and Accountability 

20 Act of 1996 (Public Law 104–191; 110 Stat. 

21 2033), or any regulation promulgated under 

22 such section; and 

23 ‘‘(C) is not in conflict with such section or 

24 any regulation promulgated under such section. 
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1 ‘‘(3) Disclosure as required by law by a pro2 vider to the Food and Drug Administration, or on 

3 a voluntary basis by a provider to a federally estab4 lished patient safety program, with respect to an Ad5 ministration-regulated product or activity for which 

6 that entity has responsibility, for the purposes of ac7 tivities related to the quality, safety, or effectiveness 

8 of such Administration-regulated product or activity. 

9 ‘‘(4) Disclosures of patient safety work product 

10 in accordance with this part by a provider to a pa11 tient safety organization. 

12 ‘‘(d) EFFECT OF TRANSFER, DISCLOSURE.—The fol13 lowing shall not be treated as a waiver of any privilege 

14 or protection established under this part: 

15 ‘‘(1) The transfer of any patient safety work 

16 product between a provider and a patient safety or17 ganization. 

18 ‘‘(2) Disclosure of patient safety work product 

19 as described in subsection (c). 

20 ‘‘(3) The unauthorized disclosure of patient 

21 safety work product. 

22 ‘‘(e) PENALTY.—

23 ‘‘(1) PROHIBITION.—Except as provided in this 

24 part, and subject to paragraphs (2) and (4), it shall 

25 be unlawful for any person to disclose patient safety 
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1 work product in violation of this section, if such dis2 closure constitutes a negligent or knowing breach of 

3 confidentiality. 

4 ‘‘(2) RELATION TO HIPAA.—The penalty 

5 under paragraph (3) for a disclosure in violation of 

6 paragraph (1) does not apply if the person would be 

7 subject to a penalty under section 264(c) of the 

8 Health Insurance Portability and Accountability Act 

9 of 1996 (Public Law 104–191; 110 Stat. 2033), or 

10 any regulation promulgated under such section, for 

11 the same disclosure. 

12 ‘‘(3) AMOUNT.—Any person who violates para13 graph (1) shall be subject to a civil monetary penalty 

14 of not more than $10,000 for each such violation in15 volved. Such penalty shall be imposed and collected 

16 in the same manner as civil money penalties under 

17 subsection (a) of section 1128A of the Social Secu18 rity Act are imposed and collected. 

19 ‘‘(4) SUBSEQUENT DISCLOSURE.—Paragraph 

20 (1) applies only to the first person that breaches 

21 confidentiality with respect to particular patient 

22 safety work product. 

23 ‘‘(f) RELATION TO HIPAA.—

24 ‘‘(1) IN GENERAL.—For purposes of applying 

25 the regulations promulgated pursuant to section
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1 264(c) of the Health Insurance Portability and Ac2 countability Act of 1996 (Public Law 104–191; 110 

3 Stat. 2033)—

4 ‘‘(A) patient safety organizations shall be 

5 treated as business associates; and 

6 ‘‘(B) activities of such organizations de7 scribed in section 921(4) in relation to a pro8 vider are deemed to be health care operations 

9 (as defined in such regulations) of the provider. 

10 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in 

11 this section shall be construed to alter or affect the 

12 implementation of such regulations or such section 

13 264(c). 

14 ‘‘(g) NO LIMITATION OF OTHER PRIVILEGES.—

15 Nothing in this section shall be construed to affect privi16 leges, including peer review and confidentiality protec17 tions, that are otherwise available under Federal or State 

18 laws. 

19 ‘‘(h) NO LIMITATION ON CONTRACTS.—Nothing in 

20 this section shall be construed to limit the power of a pro21 vider and a patient safety organization, or a patient safety 

22 organization and the Agency or any National Patient 

23 Safety Database, consistent with the provisions of this Act 

24 and other applicable law, to enter into a contract requiring 
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1 greater confidentiality or delegating authority to make an 

2 authorized disclosure. 

3 ‘‘(i) RELATION TO STATE REPORTING REQUIRE4 MENTS.—Nothing in this part shall be construed as pre5 empting or otherwise affecting any State law requiring a 

6 provider to report information, including information de7 scribed in section 921(5)(B), that is not patient safety 

8 work product. 

9 ‘‘(j) CONTINUATION OF PRIVILEGE.—Patient safety 

10 work product of an organization that is certified as a pa11 tient safety organization shall continue to be privileged 

12 and confidential, in accordance with this section, if the or13 ganization’s certification is terminated or revoked or if the 

14 organization otherwise ceases to qualify as a patient safety 

15 organization. 

16 ‘‘(k) REPORTS ON STRATEGIES TO IMPROVE PA17 TIENT SAFETY.—

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

19 that is 18 months after any National Patient Safety 

20 Database is operational, the Secretary, in consulta21 tion with the Director, shall prepare a draft report 

22 on effective strategies for reducing medical errors 

23 and increasing patient safety. The draft report shall 

24 include any measure determined appropriate by the 

25 Secretary to encourage the appropriate use of such 
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1 strategies, including use in any federally funded pro2 grams. The Secretary shall make the draft report 

3 available for public comment and submit the draft 

4 report to the Institute of Medicine for review. 

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

6 after the date described in paragraph (1), the Sec7 retary shall submit a final report to the Congress 

8 that includes, in an appendix, any findings by the 

9 Institute of Medicine concerning research on the 

10 strategies discussed in the draft report and any 

11 modifications made by the Secretary based on such 

12 findings. 

13 ‘‘SEC. 923. NATIONAL DATABASE. 

14 ‘‘(a) AUTHORITY.—

15 ‘‘(1) IN GENERAL.—In conducting activities 

16 under this part, the Secretary shall provide for the 

17 establishment and maintenance of a database to re18 ceive relevant nonidentifiable patient safety work 

19 product, and may designate entities to collect rel20 evant nonidentifiable patient safety work product 

21 that is voluntarily reported by patient safety organi22 zations upon the request of the Secretary. Any data23 base established or designated under this paragraph 

24 may be referred to as a ‘National Patient Safety 

25 Database’. 
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1 ‘‘(2) USE OF INFORMATION.—Information re2 ported to any National Patient Safety Database 

3 shall be used to analyze national and regional statis4 tics, including trends and patterns of health care er5 rors. The information resulting from such analyses 

6 may be included in the annual quality reports pre7 pared under section 913(b)(2). 

8 ‘‘(3) ADVISORY ROLE.—The Secretary shall 

9 provide scientific support to patient safety organiza10 tions, including the dissemination of methodologies 

11 and evidence-based information related to root 

12 causes and quality improvement. 

13 ‘‘(b) STANDARDS.—In establishing or designating a 

14 database under subsection (a)(1), the Secretary shall, in 

15 consultation with representatives of patient safety organi16 zations, the provider community, and the health informa17 tion technology industry, determine common formats for 

18 the voluntary reporting of nonidentifiable patient safety 

19 work product, including necessary elements, common and 

20 consistent definitions, and a standardized computer inter21 face for the processing of the work product. To the extent 

22 practicable, such standards shall be consistent with the 

23 administrative simplification provisions of part C of title 

24 XI of the Social Security Act. 
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1 ‘‘(c) CERTAIN METHODOLOGIES FOR COLLECTION.—

2 The Secretary shall ensure that the methodologies for the 

3 collection of nonidentifiable patient safety work product 

4 for any National Patient Safety Database include the 

5 methodologies developed or recommended by the Patient 

6 Safety Task Force of the Department of Health and 

7 Human Services. 

8 ‘‘(d) FACILITATION OF INFORMATION EXCHANGE.—

9 To the extent practicable, the Secretary may facilitate the 

10 direct link of information between providers and patient 

11 safety organizations and between patient safety organiza12 tions and any National Patient Safety Database. 

13 ‘‘(e) RESTRICTION ON TRANSFER.—Only nonidentifi14 able information may be transferred to any National Pa15 tient Safety Database. 

16 ‘‘SEC. 924. TECHNICAL ASSISTANCE. 

17 ‘‘(a) IN GENERAL.—The Secretary, acting through 

18 the Director, may—

19 ‘‘(1) provide technical assistance to patient 

20 safety organizations, and to States with reporting 

21 systems for health care errors; and 

22 ‘‘(2) provide guidance on the type of data to be 

23 voluntarily submitted to any National Patient Safety 

24 Database.
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1 ‘‘(b) ANNUAL MEETINGS.—Assistance provided 

2 under subsection (a) may include annual meetings for pa3 tient safety organizations to discuss methodology, commu4 nication, information collection, or privacy concerns. 

5 ‘‘SEC. 925. CERTIFICATION OF PATIENT SAFETY ORGANIZA6 TIONS. 

7 ‘‘(a) IN GENERAL.—Not later than 6 months after 

8 the date of enactment of the Patient Safety and Quality 

9 Improvement Act, the Secretary shall establish a process 

10 for certifying patient safety organizations. 

11 ‘‘(b) PROCESS.—The process established under sub12 section (a) shall include the following: 

13 ‘‘(1) Certification of patient safety organiza14 tions by the Secretary or by such other national or 

15 State governmental organizations as the Secretary 

16 determines appropriate. 

17 ‘‘(2) If the Secretary allows other governmental 

18 organizations to certify patient safety organizations 

19 under paragraph (1), the Secretary shall establish a 

20 process for approving such organizations. Any such 

21 approved organization shall conduct certifications 

22 and reviews in accordance with this section. 

23 ‘‘(3) A review of each certification under para24 graph (1) (including a review of compliance with 

25 each criterion in this section and any related imple-
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1 menting standards as determined by the Secretary 

2 through rulemaking) not less often than every 3 

3 years, as determined by the Secretary. 

4 ‘‘(4) Revocation of any such certification by the 

5 Secretary or other such governmental organization 

6 that issued the certification, upon a showing of 

7 cause. 

8 ‘‘(c) CRITERIA.—A patient safety organization must 

9 meet the following criteria as conditions of certification: 

10 ‘‘(1) The mission of the patient safety organiza11 tion is to conduct activities that are to improve pa12 tient safety and the quality of health care delivery 

13 and is not in conflict of interest with the providers 

14 that contract with the patient safety organization. 

15 ‘‘(2) The patient safety organization has appro16 priately qualified staff, including licensed or certified 

17 medical professionals. 

18 ‘‘(3) The patient safety organization, within any 

19 2 year period, contracts with more than 1 provider 

20 for the purpose of receiving and reviewing patient 

21 safety work product. 

22 ‘‘(4) The patient safety organization is not a 

23 component of a health insurer or other entity that 

24 offers a group health plan or health insurance cov25 erage. 
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1 ‘‘(5) The patient safety organization is man2 aged, controlled, and operated independently from 

3 any provider that contracts with the patient safety 

4 organization for reporting patient safety work prod5 uct. 

6 ‘‘(6) To the extent practical and appropriate, 

7 the patient safety organization collects patient safety 

8 work product from providers in a standardized man9 ner that permits valid comparisons of similar cases 

10 among similar providers. 

11 ‘‘(d) ADDITIONAL CRITERIA FOR COMPONENT ORGA12 NIZATIONS.—If a patient safety organization is a compo13 nent of another organization, the patient safety organiza14 tion must, in addition to meeting the criteria described 

15 in subsection (c), meet the following criteria as conditions 

16 of certification: 

17 ‘‘(1) The patient safety organization maintains 

18 patient safety work product separately from the rest 

19 of the organization, and establishes appropriate se20 curity measures to maintain the confidentiality of 

21 the patient safety work product. 

22 ‘‘(2) The patient safety organization does not 

23 make an unauthorized disclosure under this Act of 

24 patient safety work product to the rest of the orga25 nization in breach of confidentiality. 
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1 ‘‘(3) The mission of the patient safety organiza2 tion does not create a conflict of interest with the 

3 rest of the organization.’’. 

4 (b) AUTHORIZATION OF APPROPRIATIONS.—Section 

5 937 of the Public Health Service Act (as redesignated by 

6 subsection (a)) is amended by adding at the end the fol7 lowing: 

8 ‘‘(e) PATIENT SAFETY AND QUALITY IMPROVE9 MENT.—For the purpose of carrying out part C, there are 

10 authorized to be appropriated such sums as may be nec11 essary for each of the fiscal years 2004 through 2013.’’. 

12 SEC. 4. PROMOTING THE DIFFUSION AND INTEROPER13 ABILITY OF INFORMATION TECHNOLOGY SYS14 TEMS INVOLVED WITH HEALTH CARE DELIV15 ERY. 

16 (a) VOLUNTARY STANDARDS.—

17 (1) IN GENERAL.—Not later than 18 months 

18 after the date of the enactment of this Act, the Sec19 retary of Health and Human Services (in this sec20 tion referred to as the ‘‘Secretary’’) shall—

21 (A) develop or adopt voluntary national 

22 standards that promote the interoperability of 

23 information technology systems involved with 

24 health care delivery, including but not limited to 

25 computerized physician order entry; 
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1 (B) in developing or adopting such stand2 ards, take into account—

3 (i) the ability of such systems to cap4 ture and aggregate clinically specific data 

5 to enable evidence-based medicine and 

6 other applications that promote the elec7 tronic exchange of patient medical record 

8 information; and 

9 (ii) the cost that meeting such stand10 ards would have on providing health care 

11 in the United States and the increased effi12 ciencies in providing such care achieved 

13 under the standards; 

14 (C) in developing or adopting such stand15 ards and to the extent practicable, test the effi16 cacy, usability, and scalability of proposed inter17 operability standards within a variety of clinical 

18 settings, including an urban academic medical 

19 center, a rural hospital, a community health 

20 center, and a community hospital; and 

21 (D) submit a report to the Congress con22 taining recommendations on such standards. 

23 (2) CONSULTATION.—In developing or adopting 

24 standards under paragraph (1)(A), the Secretary 

25 shall consider the recommendations of the National
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1 Committee on Vital Health Statistics for the stand2 ardization of message formatting, coding, and vocab3 ulary for interoperability of information technology 

4 systems involved with health care delivery. The Sec5 retary shall consult with representatives of the 

6 health information technology industry and the pro7 vider community who are involved with the develop8 ment of interoperability standards. 

9 (b) UPDATES.—The Secretary shall provide for the 

10 ongoing review and periodic updating of the standards de11 veloped under subsection (a). 

12 SEC. 5. REQUIRED USE OF PRODUCT IDENTIFICATION 

13 TECHNOLOGY. 

14 The Federal Food, Drug, and Cosmetic Act (21 

15 U.S.C. 301 et seq.) is amended—

16 (1) in section 502, by adding at the end the fol17 lowing: 

18 ‘‘(w) If it is a drug or biological product, unless it 

19 includes a unique product identifier for the drug or bio20 logical product as required by regulations under section 

21 510(q).’’; and 

22 (2) in section 510, by adding at the end the fol23 lowing: 

24 ‘‘(q)(1) The Secretary shall issue, and may periodi25 cally revise, regulations requiring the manufacturer of any 
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1 drug or biological product that is subject to regulation by 

2 the Food and Drug Administration, or the packager or 

3 labeler of a drug or biological product that is subject to 

4 regulation by the Food and Drug Administration, to in5 clude a unique product identifier on the packaging of the 

6 drug or biological product. 

7 ‘‘(2) For purposes of this subsection, the term 

8 ‘unique product identifier’ means an identification that—

9 ‘‘(A) is affixed by the manufacturer, labeler, or 

10 packager to each drug or biological product de11 scribed in paragraph (1) at each packaging level; 

12 ‘‘(B) uniquely identifies the item and meets the 

13 standards required by this section; and 

14 ‘‘(C) can be read by a scanning device or other 

15 technology acceptable to the Secretary. 

16 ‘‘(3) A unique product identifier required by regula17 tions issued or revised under paragraph (1) shall be based 

18 on—

19 ‘‘(A) the National Drug Code maintained by 

20 the Food and Drug Administration; 

21 ‘‘(B) commercially accepted standards estab22 lished by organizations that are accredited by the 

23 American National Standards Institute, such as the 

24 Health Industry Business Communication Council or 

25 the Uniform Code Council; or 
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1 ‘‘(C) other identification formats that the Sec2 retary deems appropriate. 

3 ‘‘(4) The Secretary may, at the Secretary’s discre4 tion, waive the requirements of this section, or add addi5 tional provisions that are necessary to safeguard the pub6 lic health.’’.

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