109 HR 3205 IH: Patient Safety and Quality Improvement Act
U.S. House of Representatives
2005-07-12
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.Short title; table of contents
(a)This Act may be cited as the Patient Safety and Quality Improvement Act
.
(b)The table of contents for this Act is as follows:
Sec. 1. Short title; table of contents
Sec. 2. Findings and purposes
Title I—Patient safety and quality improvement
Sec. 101. Amendments to Public Health Service Act
Sec. 102. Promoting the diffusion and interoperability of information technology systems involved with health care delivery
Sec. 103. Required use of product identification technology
Sec. 104. Grants for electronic prescription programs
Sec. 105. Grants to hospitals and other health care providers for information technologies
Sec. 106. Authorization of appropriations for grants under sections 104 and 105
Title II—Medical Information Technology Advisory Board
Sec. 201. Medical Information Technology Advisory Board
2.
(a)The Congress finds as follows:
(1)In 1999, the Institute of Medicine released a report entitled To Err Is Human
that described medical errors as the 8th leading cause of death in the United States, with as many as 98,000 people dying as a result of medical errors each year.
(2)To address these deaths and injuries due to medical errors, the health care system must identify and learn from such errors so that systems of care can be improved.
(3)Myriad public and private patient safety initiatives have begun. The Quality Interagency Coordination Task Force has recommended steps to improve patient safety that may be taken by each Federal agency involved in health care and activities relating to these steps are ongoing.
(4)The Department of Health and Human Services has initiated several patient safety projects. The Joint Commission on Accreditation of Healthcare Organizations issued a patient safety standard that went into effect on July 1, 2001, and the peer review organizations are conducting ongoing studies of clinical performance measurement of care delivered to beneficiaries under the medicare program under title XVIII of the Social Security Act.
(5)Several steps can be taken now to improve patient safety. For example, according to the Centers for Disease Control and Prevention, hand washing is the single most important means of preventing the spread of infection. Repeated studies indicate that lack of or improper hand washing still contributes significantly to disease transmission in health care settings. Working with experts from the private sector, the Centers for Disease Control and Prevention has drafted Guidelines for Hand Hygiene in Healthcare Settings
setting forth recommendations to promote improved hand hygiene practices and reduce transmission of pathogenic microorganisms to patients and personnel in health care settings.
(6)According to the Centers for Disease Control and Prevention, nosocomial infections affect approximately 2 million patients annually in acute care facilities in the United States at an estimated direct patient care cost of approximately $3.5 billion each year.
(7)The Congress encourages the continuation and acceleration of private sector efforts to take immediate steps to improve patient safety and recognizes the need for action in the public sector to complement these efforts.
(8)The research on patient safety unequivocally calls for a learning environment, where providers will feel safe to report health care errors, in order to improve patient safety.
(9)Voluntary data gathering systems are more supportive than mandatory systems in creating the learning environment referred to in paragraph (8) as stated in the Institute of Medicine’s report.
(10)Promising patient safety reporting systems have been established throughout the United States, and the best ways to structure and use these systems are currently being determined, largely through projects funded by the Agency for Healthcare Research and Quality.
(11)Many organizations currently collecting patient safety information have expressed a need for protections that will allow them to review protected information so that they may collaborate in the development and implementation of patient safety improvement strategies. Currently, the State peer review protections provide inadequate conditions to allow the sharing of information to promote patient safety.
(12)In 2001, the Institute of Medicine released a report entitled Crossing the Quality Chasm
that found that the United States health care system does not consistently deliver high-quality care to patients.
(b)The purposes of this Act are—
(1)to encourage a culture of safety and quality in the United States health care system by providing for a health care errors reporting system that both protects information and improves patient safety and quality of health care; and
(2)to ensure accountability by raising standards and expectations for continuous quality improvements in patient safety through the actions of the Secretary of Health and Human Services.
<enum>I</enum><header>Patient safety and quality improvement</header>
<section id="HD431B7BB47E64E4F009FCA831BCED671"><enum>101.</enum><header>Amendments to <act-name parsable-cite="PHSA">Public Health Service Act</act-name></header>
<subsection id="H95F02D268B46489084DDAE3C24EB7193"><enum>(a)</enum><header>In general</header><text>Title IX of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/299">42 U.S.C. 299 et seq.</external-xref>) is amended—</text>
<paragraph id="H694973D33368477FBA069654E000FB99"><enum>(1)</enum><text>in section 912(c), by inserting <quote>, in accordance with part C,</quote> after <quote>The Director shall</quote>;</text></paragraph>
<paragraph id="HA1AB2FB6FA104EBFA634D0D6704E95F4"><enum>(2)</enum><text>by redesignating part C as part D;</text></paragraph>
<paragraph id="H74E0F789E56C4C6DA2A91CC1265D5197"><enum>(3)</enum><text>by redesignating sections 921 through 928, as sections 931 through 938, respectively;</text></paragraph>
<paragraph id="HDCE3D48894B24F618142338C12CF42ED"><enum>(4)</enum><text>in section 938(1) (as so redesignated), by striking <quote>921</quote> and inserting <quote>931</quote>; and</text></paragraph>
<paragraph id="HAB8480791D7A424FAD3ECE00942C38AF"><enum>(5)</enum><text>by inserting after part B the following:</text>
<quoted-block id="H0B4F1291B24148D9A7853083ADCB7762">
<part id="H7611CDB359AB49E0974CCEF808ED85"><enum>C</enum><header>Patient safety improvement</header>
<section id="H8F0D6084AEE84696BDC95766C0971029"><enum>921.</enum><header>Definitions</header><text display-inline="no-display-inline">In this part:</text>
<paragraph id="H3E6F5A05F7A54858ACCC00027D87B88C"><enum>(1)</enum><header>Identifiable information</header><text>The term <term>identifiable information</term> means information that is presented in a form and manner that allows the identification of any provider, patient, or reporter of patient safety work product. With respect to patients, such information includes any individually identifiable health information as that term is defined in the regulations promulgated pursuant to section 264(c) of the <act-name parsable-cite="HIPAA">Health Insurance Portability and Accountability Act of 1996</act-name> (<external-xref legal-doc="public-law" parsable-cite="pl/104/191">Public Law 104–191</external-xref>; 110 Stat. 2033).</text></paragraph>
<paragraph id="H32DAFEF5A714468AA778D452ACC66921"><enum>(2)</enum><header>Nonidentifiable information</header><text>The term <term>nonidentifiable information</term> means information that is presented in a form and manner that prevents the identification of any provider, patient, or reporter of patient safety work product. With respect to patients, such information must be de-identified consistent with the regulations promulgated pursuant to section 264(c) of the <act-name parsable-cite="HIPAA">Health Insurance Portability and Accountability Act of 1996</act-name> (<external-xref legal-doc="public-law" parsable-cite="pl/104/191">Public Law 104–191</external-xref>; 110 Stat. 2033).</text></paragraph>
<paragraph id="HF17FFE51F8D24B8784224C8D009EDD81"><enum>(3)</enum><header>Patient safety evaluation system</header><text>The term <term>patient safety evaluation system</term> means a process that involves the collection, management, or analysis of information for submission to or by a patient safety organization.</text></paragraph>
<paragraph id="H4BC704ABD93446E4A2102DAEF8B0F211"><enum>(4)</enum><header>Patient safety organization</header><text>The term <term>patient safety organization</term> means a private or public organization or component thereof that is certified, through a process to be determined by the Secretary under section 925, to perform each of the following activities:</text>
<subparagraph id="HAFBA3566105441499572BC55A24F68C3"><enum>(A)</enum><text>The conduct, as the organization or component’s primary activity, of efforts to improve patient safety and the quality of health care delivery.</text></subparagraph>
<subparagraph id="HADB950494945464BB0F58362F8502570"><enum>(B)</enum><text>The collection and analysis of patient safety work product that is submitted by providers.</text></subparagraph>
<subparagraph id="HE253DF1C3E4B45BEA4EE63796E31FBA1"><enum>(C)</enum><text>The development and dissemination of evidence-based information to providers with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices.</text></subparagraph>
<subparagraph id="H7F6CEAEACF4B469090FF99E908C7B967"><enum>(D)</enum><text>The utilization of patient safety work product to carry out activities limited to those described under this paragraph and for the purposes of encouraging a culture of safety and of providing direct feedback and assistance to providers to effectively minimize patient risk.</text></subparagraph>
<subparagraph id="HFC0B604E03D8439D89BF43D62E48B66"><enum>(E)</enum><text>The maintenance of confidentiality with respect to identifiable information.</text></subparagraph>
<subparagraph id="HB1AAEDCC1B444A1CB4C78FF109CA0033"><enum>(F)</enum><text>The provision of appropriate security measures with respect to patient safety work product.</text></subparagraph>
<subparagraph id="H54D29104F35246B4A3F5A72E3F002357"><enum>(G)</enum><text>The submission of nonidentifiable information to the Agency consistent with standards established by the Secretary under section 923(b) for any National Patient Safety Database.</text></subparagraph></paragraph>
<paragraph id="H6394267D9424499B9E1F5E375FED97FC"><enum>(5)</enum><header>Patient safety work product</header>
<subparagraph id="H68966346A5E94F8FB5CD214449E6324C"><enum>(A)</enum><text>The term <term>patient safety work product</term> means any document or communication (including any information, report, record, memorandum, analysis, deliberative work, statement, or root cause analysis) that—</text>
<clause id="HDE42B4E52C3740759016D1037288D2A0"><enum>(i)</enum><text>except as provided in subparagraph (B), is developed by a provider for the purpose of reporting to a patient safety organization, and is reported to a patient safety organization;</text></clause>
<clause id="H8E4F1BC7277442C39332C02BD068209B"><enum>(ii)</enum><text>is created by a patient safety organization; or</text></clause>
<clause id="H9B5C5FA4DEC840BCB592C2A1E729B7E5"><enum>(iii)</enum><text>would reveal the deliberations or analytic process of a patient safety evaluation system (as defined in paragraph (3)).</text></clause></subparagraph>
<subparagraph id="HDE2AD54B99244671ACB737C819DA4077"><enum>(B)</enum>
<clause display-inline="yes-display-inline" id="HD7ECF8A8C2C34E4B8B793B0059DC6BF2"><enum>(i)</enum><text>Patient safety work product described in subparagraph (A)(i)—</text>
<subclause indent="clause" id="H1E210CE3389443B7964C67FCAAAF1B4C"><enum>(I)</enum><text>does not include any separate information described in clause (ii); and</text></subclause>
<subclause indent="clause" id="H5612B9C10E81432DAE8D3010CC00E5FA"><enum>(II)</enum><text>shall not be construed to include such separate information merely by reason of inclusion of a copy of the document or communication involved in a submission to, or the fact of submission of such a copy to, a patient safety organization.</text></subclause></clause>
<clause indent="subparagraph" id="HB6038B67EEB2409D86009ED363AFAB00"><enum>(ii)</enum><text>Separate information described in this clause is a document or communication (including a patient’s medical record or any other patient or hospital record) that is developed or maintained, or exists, separately from any patient safety evaluation system.</text></clause></subparagraph>
<subparagraph id="H818B83316BD14844B3DF31E74E574430"><enum>(C)</enum><text>Information available from sources other than a patient safety work product under this section may be discovered or admitted in a civil or administrative proceeding, if discoverable or admissible under applicable law.</text></subparagraph></paragraph>
<paragraph id="HEEA108C004304410BEE84CA9008F8314"><enum>(6)</enum><header>Provider</header><text>The term <term>provider</term> means—</text>
<subparagraph id="H9E9F641F068B4F12921B580400FAB341"><enum>(A)</enum><text>an individual or entity licensed or otherwise authorized under State law to provide health care services, including—</text>
<clause id="H90BFC095E399476F9D7FB006FF116E6"><enum>(i)</enum><text>a hospital, nursing facility, comprehensive outpatient rehabilitation facility, home health agency, and hospice program;</text></clause>
<clause id="H8D6C7DFC03D04E4898B21816353BE99"><enum>(ii)</enum><text>a physician, physician assistant, nurse practitioner, clinical nurse specialist, certified nurse midwife, nurse anesthetist, psychologist, certified social worker, registered dietitian or nutrition professional, physical or occupational therapist, or other individual health care practitioner;</text></clause>
<clause id="HD681F26A2D2F4B90AAE4E53CDF3F79A3"><enum>(iii)</enum><text>a pharmacist; and</text></clause>
<clause id="HCC2A34D13A304C9890CAF99929714E00"><enum>(iv)</enum><text>a renal dialysis facility, ambulatory surgical center, pharmacy, physician or health care practitioner’s office, long-term care facility, behavioral health residential treatment facility, clinical laboratory, or community health center; or</text></clause></subparagraph>
<subparagraph id="H4B0652199D5543CFB9C7E29B762C16"><enum>(B)</enum><text>any other person or entity specified in regulations by the Secretary after public notice and comment.</text></subparagraph></paragraph></section>
<section id="HA7C073C66FFB4B49AECE0393D171211F"><enum>922.</enum><header>Privilege for patient safety work product</header>
<subsection id="H484A99F7946C496C90D5A6ED8B12F4D9"><enum>(a)</enum><header>Privilege</header><text>Notwithstanding any other provision of law and subject to subsection (c), patient safety work product shall not be—</text>
<paragraph id="H6A75FB75B36A4630AF7100C8A8F7FDBD"><enum>(1)</enum><text>subject to a civil or administrative subpoena or order;</text></paragraph>
<paragraph id="H5B9D6F1173434A21A4266340EF493952"><enum>(2)</enum><text>subject to discovery in connection with a civil or administrative proceeding;</text></paragraph>
<paragraph id="HBC07A4374DCB4F1DA9F87161876B2E07"><enum>(3)</enum><text>subject to disclosure pursuant to <external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552</external-xref> of title 5, United States Code (commonly known as the Freedom of Information Act), or any other similar Federal or State law;</text></paragraph>
<paragraph id="H327212FFFAE04FEEABF093E68FC3B00"><enum>(4)</enum><text>required to be admitted as evidence or otherwise disclosed in any State or Federal civil or administrative proceeding; or</text></paragraph>
<paragraph id="H48829C53F1D641109B4E2B49ED5706C"><enum>(5)</enum><text>if the patient safety work product is identifiable information and is received by a national accreditation organization in its capacity as a patient safety organization—</text>
<subparagraph id="HAA1CA944D3374C09A39CE2E87E4F91C8"><enum>(A)</enum><text>used by a national accreditation organization in an accreditation action against the provider that reported the information;</text></subparagraph>
<subparagraph id="H781CB2F3C0704BB181D926DD10CD1F63"><enum>(B)</enum><text>shared by such organization with its survey team; or</text></subparagraph>
<subparagraph id="H48239637526E465F80659300B3ACA061"><enum>(C)</enum><text>required as a condition of accreditation by a national accreditation association.</text></subparagraph></paragraph></subsection>
<subsection id="HABAF1DC1E428407A956E5D8E0041A6B5"><enum>(b)</enum><header>Reporter protection</header>
<paragraph id="H6A794FDF733D48618EBD3F32A1A2A79F"><enum>(1)</enum><header>In general</header><text>A 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 information—</text>
<subparagraph id="H23589DFDD11042FA996CC301A9DC507F"><enum>(A)</enum><text>to the provider with the intention of having the information reported to a patient safety organization; or</text></subparagraph>
<subparagraph id="HACF8B78816AC467F952DE588CC5897B9"><enum>(B)</enum><text>directly to a patient safety organization.</text></subparagraph></paragraph>
<paragraph id="H3E9C9E3A88894816A8DC4E9FFBDE7EAF"><enum>(2)</enum><header>Adverse employment action</header><text>For purposes of this subsection, an <quote>adverse employment action</quote> includes—</text>
<subparagraph id="HC4AD2150F2A342ED9C111C66D2C9C4F7"><enum>(A)</enum><text>the failure to promote an individual or provide any other employment-related benefit for which the individual would otherwise be eligible;</text></subparagraph>
<subparagraph id="H9287F7BCB3D4495FAA55B1199733A3C8"><enum>(B)</enum><text>an adverse evaluation or decision made in relation to accreditation, certification, credentialing, or licensing of the individual; and</text></subparagraph>
<subparagraph id="H384012558E1645B9AD44F982A57037EF"><enum>(C)</enum><text>a personnel action that is adverse to the individual concerned.</text></subparagraph></paragraph>
<paragraph id="H7D7B71B84F8C47C2A9DB79A7F2A8AC6"><enum>(3)</enum><header>Remedies</header><text>Any provider that violates this subsection shall be subject to a civil monetary penalty of not more than $20,000 for each such violation involved. Such penalty shall be imposed and collected in the same manner as civil money penalties under subsection (a) of section 1128A of the <act-name parsable-cite="SSA">Social Security Act</act-name> are imposed and collected.</text></paragraph></subsection>
<subsection id="HF3BA91D4483543F9B2F580097D887291"><enum>(c)</enum><header>Disclosures</header><text>Nothing in this section prohibits any of the following disclosures:</text>
<paragraph id="H8298F44F8C8A41EB8199734196006D5C"><enum>(1)</enum><text>Voluntary disclosure of nonidentifiable information.</text></paragraph>
<paragraph id="H992043E9D6B247049F2312CEA793776B"><enum>(2)</enum><text>Voluntary disclosure of identifiable information by a provider or patient safety organization, if such disclosure—</text>
<subparagraph id="H47DE948DEC7D42D2B495809694A0CC5D"><enum>(A)</enum><text>is authorized by the provider for the purposes of improving quality and safety;</text></subparagraph>
<subparagraph id="H14254BF4CEB44DFEA01D420000903892"><enum>(B)</enum><text>is to an entity or person subject to the requirements of section 264(c) of the <act-name parsable-cite="HIPAA">Health Insurance Portability and Accountability Act of 1996</act-name> (<external-xref legal-doc="public-law" parsable-cite="pl/104/191">Public Law 104–191</external-xref>; 110 Stat. 2033), or any regulation promulgated under such section; and</text></subparagraph>
<subparagraph id="HE604FC12BFB44F758F13A5612E147887"><enum>(C)</enum><text>is not in conflict with such section or any regulation promulgated under such section.</text></subparagraph></paragraph>
<paragraph id="H0918259E08BF4A3DAF4028BDC4EA25FE"><enum>(3)</enum><text>Disclosure as required by law by a provider to the Food and Drug Administration, or on a voluntary basis by a provider to a federally established patient safety program, with respect to an Administration-regulated product or activity for which that entity has responsibility, for the purposes of activities related to the quality, safety, or effectiveness of such Administration-regulated product or activity.</text></paragraph>
<paragraph id="H6FC25109369D45A283AC2161DC91387F"><enum>(4)</enum><text>Disclosures of patient safety work product in accordance with this part by a provider to a patient safety organization.</text></paragraph></subsection>
<subsection id="H656C4AA75C2D49CE9B82DABF81EBEC15"><enum>(d)</enum><header>Effect of transfer, disclosure</header><text>The following shall not be treated as a waiver of any privilege or protection established under this part:</text>
<paragraph id="H57681FBBB1334EF29879B3B761AF8B42"><enum>(1)</enum><text>The transfer of any patient safety work product between a provider and a patient safety organization.</text></paragraph>
<paragraph id="HD781B2B075E243F38D3FE2632237B2F"><enum>(2)</enum><text>Disclosure of patient safety work product as described in subsection (c).</text></paragraph>
<paragraph id="HEE947F94417B42AA88B0522F1D1DA245"><enum>(3)</enum><text>The unauthorized disclosure of patient safety work product.</text></paragraph></subsection>
<subsection id="HFA649D6611E1419D82FCA9E149212075"><enum>(e)</enum><header>Penalty</header>
<paragraph id="H77198B3CC8ED45AE98CB88DCF9A2700"><enum>(1)</enum><header>Prohibition</header><text>Except as provided in this part, and subject to paragraphs (2) and (4), it shall be unlawful for any person to disclose patient safety work product in violation of this section, if such disclosure constitutes a negligent or knowing breach of confidentiality.</text></paragraph>
<paragraph id="H6A6C43B7DF734ED49372162CE000F633"><enum>(2)</enum><header>Relation to HIPAA</header><text>The penalty under paragraph (3) for a disclosure in violation of paragraph (1) does not apply if the person would be subject to a penalty under section 264(c) of the <act-name parsable-cite="HIPAA">Health Insurance Portability and Accountability Act of 1996</act-name> (<external-xref legal-doc="public-law" parsable-cite="pl/104/191">Public Law 104–191</external-xref>; 110 Stat. 2033), or any regulation promulgated under such section, for the same disclosure.</text></paragraph>
<paragraph id="HCE4376AE261E4BE58806B29BF1767231"><enum>(3)</enum><header>Amount</header><text>Any person who violates paragraph (1) shall be subject to a civil monetary penalty of not more than $10,000 for each such violation involved. Such penalty shall be imposed and collected in the same manner as civil money penalties under subsection (a) of section 1128A of the <act-name parsable-cite="SSA">Social Security Act</act-name> are imposed and collected.</text></paragraph>
<paragraph id="H384F191EA2BA46F7ABF98202EDF44938"><enum>(4)</enum><header>Subsequent disclosure</header><text>Paragraph (1) applies only to the first person that breaches confidentiality with respect to particular patient safety work product.</text></paragraph></subsection>
<subsection id="HD203B94CD5554AEEAA5D9074B1312C65"><enum>(f)</enum><header>Relation to HIPAA</header>
<paragraph id="H80F5A510A5834F53A72463EC51F4AED8"><enum>(1)</enum><header>In general</header><text>For purposes of applying the regulations promulgated pursuant to section 264(c) of the <act-name parsable-cite="HIPAA">Health Insurance Portability and Accountability Act of 1996</act-name> (<external-xref legal-doc="public-law" parsable-cite="pl/104/191">Public Law 104–191</external-xref>; 110 Stat. 2033)—</text>
<subparagraph id="HC9248DDBC55C4A97BBDBFA3B57D7F79"><enum>(A)</enum><text>patient safety organizations shall be treated as business associates; and</text></subparagraph>
<subparagraph id="H03DA678423954257A25BBC600817FAE"><enum>(B)</enum><text>activities of such organizations described in section 921(4) in relation to a provider are deemed to be health care operations (as defined in such regulations) of the provider.</text></subparagraph></paragraph>
<paragraph id="H20371902EB84451F84306942C3C202F1"><enum>(2)</enum><header>Rule of construction</header><text>Nothing in this section shall be construed to alter or affect the implementation of such regulations or such section 264(c).</text></paragraph></subsection>
<subsection id="H8E7314AC4EDD4076BF56E0005EE69F20"><enum>(g)</enum><header>No limitation of other privileges</header><text>Nothing in this section shall be construed to affect privileges, including peer review and confidentiality protections, that are otherwise available under Federal or State laws.</text></subsection>
<subsection id="H96C79AB2D8BF4260AE7487C9C05A407"><enum>(h)</enum><header>No limitation on contracts</header><text>Nothing in this section shall be construed to limit the power of a provider and a patient safety organization, or a patient safety organization and the Agency or any National Patient Safety Database, consistent with the provisions of this Act and other applicable law, to enter into a contract requiring greater confidentiality or delegating authority to make an authorized disclosure.</text></subsection>
<subsection id="H7BD9D8B3BD10465A8BC47FA31DE4D932"><enum>(i)</enum><header>Relation to State reporting requirements</header><text>Nothing in this part shall be construed as preempting or otherwise affecting any State law requiring a provider to report information, including information described in section 921(5)(B), that is not patient safety work product.</text></subsection>
<subsection id="H34D8534879CC49939E1E7FCF0591905"><enum>(j)</enum><header>Continuation of privilege</header><text>Patient safety work product 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.</text></subsection>
<subsection id="H9BF8781AB86F4646A5E9D0AB7C779054"><enum>(k)</enum><header>Reports on strategies to improve patient safety</header>
<paragraph id="H091091AE501A4B88B2BFBA8F066F82BC"><enum>(1)</enum><header>Draft report</header><text>Not later than the date that is 18 months after any National Patient Safety Database is operational, the Secretary, in consultation with the Director, shall prepare a draft report on effective strategies for reducing medical errors and increasing patient safety. The draft report shall include any measure determined appropriate by the Secretary to encourage the appropriate use of such strategies, including use in any federally funded programs. The Secretary shall make the draft report available for public comment and submit the draft report to the Institute of Medicine for review.</text></paragraph>
<paragraph id="H5CFA6CBA240D4B088DBB56AF04FA5DF"><enum>(2)</enum><header>Final report</header><text>Not later than 1 year after the date described in paragraph (1), the Secretary shall submit a final report to the Congress that includes, in an appendix, any findings by the Institute of Medicine concerning research on the strategies discussed in the draft report and any modifications made by the Secretary based on such findings.</text></paragraph></subsection></section>
<section id="H5A07792C51584E6694F2EA7252B8C6BA"><enum>923.</enum><header>National Patient Safety Database</header>
<subsection id="H91D2A2577BBB4FFABABB00749FDB00BE"><enum>(a)</enum><header>Authority</header>
<paragraph id="HC765A00E6E854D8E95C888D8574E0B5"><enum>(1)</enum><header>In general</header><text>In conducting activities under this part, the Secretary shall provide for the establishment and maintenance of a database to receive relevant nonidentifiable patient safety work product, and may designate entities to collect relevant nonidentifiable patient safety work product that is voluntarily reported by patient safety organizations upon the request of the Secretary. Any database established or designated under this paragraph may be referred to as a <quote>National Patient Safety Database</quote>.</text></paragraph>
<paragraph id="HF082254F9C354910B3A9E09DE246BBDE"><enum>(2)</enum><header>Use of information</header><text>Information reported to any National Patient Safety Database shall be used to analyze national and regional statistics, including trends and patterns of health care errors. The information resulting from such analyses may be included in the annual quality reports prepared under section 913(b)(2).</text></paragraph>
<paragraph id="HA34DF956811044E4A0C0D9B7EE263212"><enum>(3)</enum><header>Advisory role</header><text>The Secretary shall provide scientific support to patient safety organizations, including the dissemination of methodologies and evidence-based information related to root causes and quality improvement.</text></paragraph></subsection>
<subsection id="H422E4756971B4C439870D6BD8CE679B"><enum>(b)</enum><header>Standards</header><text>In establishing or designating a database under subsection (a)(1), the Secretary shall, in consultation with representatives of patient safety organizations, the provider community, and the health information technology industry, determine common formats for the voluntary reporting of nonidentifiable patient safety work product, including necessary elements, common and consistent definitions, and a standardized computer interface for the processing of the work product. To the extent practicable, such standards shall be consistent with the administrative simplification provisions of part C of title XI of the <act-name parsable-cite="SSA">Social Security Act</act-name>.</text></subsection>
<subsection id="H43CE5B14814C42F5B79381B1C179CA02"><enum>(c)</enum><header>Certain methodologies for collection</header><text>The Secretary shall ensure that the methodologies for the collection of nonidentifiable patient safety work product for any National Patient Safety Database include the methodologies developed or recommended by the Patient Safety Task Force of the Department of Health and Human Services.</text></subsection>
<subsection id="H2CFD918EEC3D4582B2BE799537734234"><enum>(d)</enum><header>Facilitation of information exchange</header><text>To the extent practicable, the Secretary may facilitate the direct link of information between providers and patient safety organizations and between patient safety organizations and any National Patient Safety Database.</text></subsection>
<subsection id="HFD0BA41A619B4F7E998D4E40DF512036"><enum>(e)</enum><header>Restriction on transfer</header><text>Only nonidentifiable information may be transferred to any National Patient Safety Database.</text></subsection></section>
<section id="H406CE2F1C39844D584CE31D660009507"><enum>924.</enum><header>Technical assistance</header>
<subsection id="H4AD6D27324A347CA9392D0A282859F6D"><enum>(a)</enum><header>In general</header><text>The Secretary, acting through the Director, may—</text>
<paragraph id="H062EB685B47C4EBBB64410AB7FC28636"><enum>(1)</enum><text>provide technical assistance to patient safety organizations, and to States with reporting systems for health care errors; and</text></paragraph>
<paragraph id="HCAAABF86A0AB4CDEA48C12B0A9C79979"><enum>(2)</enum><text>provide guidance on the type of data to be voluntarily submitted to any National Patient Safety Database.</text></paragraph></subsection>
<subsection id="H143AE61AD2274AB9ABAB38CD00F78332"><enum>(b)</enum><header>Annual meetings</header><text>Assistance provided under subsection (a) may include annual meetings for patient safety organizations to discuss methodology, communication, information collection, or privacy concerns.</text></subsection></section>
<section id="HA1C4D2EE6ABD488782D8411DAC35F7E3"><enum>925.</enum><header>Certification of patient safety organizations</header>
<subsection id="H82C27429B9C8442AB9391E76DE7BA719"><enum>(a)</enum><header>In general</header><text>Not later than 6 months after the date of enactment of the Patient Safety and Quality Improvement Act, the Secretary shall establish a process for certifying patient safety organizations.</text></subsection>
<subsection id="H83F4930AA73B48C4BAEDC4B0FD41C8EF"><enum>(b)</enum><header>Process</header><text>The process established under subsection (a) shall include the following:</text>
<paragraph id="H81AB99ACD14D4FBB8FAA886E53B13D35"><enum>(1)</enum><text>Certification of patient safety organizations by the Secretary or by such other national or State governmental organizations as the Secretary determines appropriate.</text></paragraph>
<paragraph id="H88D4CF207C5C498C8D633B8225AAEB15"><enum>(2)</enum><text>If the Secretary allows other governmental organizations to certify patient safety organizations under paragraph (1), the Secretary shall establish a process for approving such organizations. Any such approved organization shall conduct certifications and reviews in accordance with this section.</text></paragraph>
<paragraph id="HFDBBA2B0A69A4564831CFCB15B4DF511"><enum>(3)</enum><text>A review of each certification under paragraph (1) (including a review of compliance with each criterion in this section and any related implementing standards as determined by the Secretary through rulemaking) not less often than every 3 years, as determined by the Secretary.</text></paragraph>
<paragraph id="HA60E8D2234A844C780717FA8BFB525E"><enum>(4)</enum><text>Revocation of any such certification by the Secretary or other such governmental organization that issued the certification, upon a showing of cause.</text></paragraph></subsection>
<subsection id="H6E1BA879CA0A437CA73F12EA095D7BA9"><enum>(c)</enum><header>Criteria</header><text>A patient safety organization must meet the following criteria as conditions of certification:</text>
<paragraph id="H30C39857BFF84496A12D109395009FFA"><enum>(1)</enum><text>The mission of the patient safety organization is to conduct activities that are to improve patient safety and the quality of health care delivery and is not in conflict of interest with the providers that contract with the patient safety organization.</text></paragraph>
<paragraph id="HF0752168136540720006EB2DDDE27EFB"><enum>(2)</enum><text>The patient safety organization has appropriately qualified staff, including licensed or certified medical professionals.</text></paragraph>
<paragraph id="H56216B4F4117418CB81DDFC39EE2E594"><enum>(3)</enum><text>The patient safety organization, within any 2 year period, contracts with more than 1 provider for the purpose of receiving and reviewing patient safety work product.</text></paragraph>
<paragraph id="H3AD820572F56464D891DB7ABFEC9409"><enum>(4)</enum><text>The patient safety organization is not a component of a health insurer or other entity that offers a group health plan or health insurance coverage.</text></paragraph>
<paragraph id="H9746C64BD3494EF696F861AA6912EAA1"><enum>(5)</enum><text>The patient safety organization is managed, controlled, and operated independently from any provider that contracts with the patient safety organization for reporting patient safety work product.</text></paragraph>
<paragraph id="HEDE02723F09B4E7085E6BE6410B23351"><enum>(6)</enum><text>To the extent practical and appropriate, the patient safety organization collects patient safety work product from providers in a standardized manner that permits valid comparisons of similar cases among similar providers.</text></paragraph></subsection>
<subsection id="H5711376D744641EEA25F00441DBFC61"><enum>(d)</enum><header>Additional criteria for component organizations</header><text>If a patient safety organization is a component of another organization, the patient safety organization must, in addition to meeting the criteria described in subsection (c), meet the following criteria as conditions of certification:</text>
<paragraph id="H756AE373218E41629801159B5254F7D5"><enum>(1)</enum><text>The patient safety organization maintains patient safety work product separately from the rest of the organization, and establishes appropriate security measures to maintain the confidentiality of the patient safety work product.</text></paragraph>
<paragraph id="H5A271309115F4F54BB5F63DD3C090843"><enum>(2)</enum><text>The patient safety organization does not make an unauthorized disclosure under this Act of patient safety work product to the rest of the organization in breach of confidentiality.</text></paragraph>
<paragraph id="H06C13722DA194FFEBED5918F5E797681"><enum>(3)</enum><text>The mission of the patient safety organization does not create a conflict of interest with the rest of the organization.</text></paragraph></subsection></section></part><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></subsection>
<subsection id="HA05F0045F33E467096265C613BD55772"><enum>(b)</enum><header>Authorization of appropriations</header><text>Section 937 of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (as redesignated by subsection (a)) is amended by adding at the end the following:</text>
<quoted-block act-name="Public Health Service Act" id="HB5A388136BED42B1BB76DD54E4645E49">
<subsection id="H77C744CDC14E4EB5A9BE004F331D7EDF"><enum>(e)</enum><header>Patient safety and quality improvement</header><text>For the purpose of carrying out part C, there are authorized to be appropriated such sums as may be necessary for each of the fiscal years 2006 through 2010.</text></subsection><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section>
<section id="H1052CE89929342BDADEC31C9DAFB78C3"><enum>102.</enum><header>Promoting the diffusion and interoperability of information technology systems involved with health care delivery</header>
<subsection id="HD6B76766EF084230B5CB2E579B006CF2"><enum>(a)</enum><header>Voluntary standards</header>
<paragraph id="HD14F480CE27643F89E45003430DD347"><enum>(1)</enum><header>In general</header><text>Not later than 18 months after the date of the enactment of this Act, the Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall—</text>
<subparagraph id="HC371B4C0693943E7B513EB96BBA17776"><enum>(A)</enum><text>develop or adopt voluntary national standards that promote the interoperability of information technology systems involved with health care delivery, including but not limited to computerized physician order entry;</text></subparagraph>
<subparagraph id="HDB0664D5E55147D4B823C83F69B7DB91"><enum>(B)</enum><text>in developing or adopting such standards, take into account—</text>
<clause id="HD03A0579018C433C904ECB176B8646DF"><enum>(i)</enum><text>the ability of such systems to capture and aggregate clinically specific data to enable evidence-based medicine and other applications that promote the electronic exchange of patient medical record information; and</text></clause>
<clause id="HB2B39DF907194EFFB37D13C1ED27677C"><enum>(ii)</enum><text>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;</text></clause></subparagraph>
<subparagraph id="HD0EDC98550044404804DA339200358F"><enum>(C)</enum><text>in developing or adopting such standards and to the extent practicable, test the efficacy, usability, and scalability of proposed interoperability standards within a variety of clinical settings, including an urban academic medical center, a rural hospital, a community health center, and a community hospital; and</text></subparagraph>
<subparagraph id="H940A255F973748F7861C5206E5B200E8"><enum>(D)</enum><text>submit a report to the Congress containing recommendations on such standards.</text></subparagraph></paragraph>
<paragraph id="H7622D33C91244EAF91A0BC00B08D4861"><enum>(2)</enum><header>Consultation</header><text>In developing or adopting standards under paragraph (1)(A), the Secretary shall consider the recommendations of the National Committee on Vital Health Statistics for the standardization of message formatting, coding, and vocabulary for interoperability of information technology systems involved with health care delivery. The Secretary shall consult with representatives of the health information technology industry and the provider community who are involved with the development of interoperability standards.</text></paragraph></subsection>
<subsection id="H34F205D6CC464E0C95C878683E3EBEFD"><enum>(b)</enum><header>Updates</header><text>The Secretary shall provide for the ongoing review and periodic updating of the standards developed under subsection (a).</text></subsection></section>
<section id="H7DE6442BD3074101B37C7DC682C23B95"><enum>103.</enum><header>Required use of product identification technology</header><text display-inline="no-display-inline">The <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>) is amended—</text>
<paragraph id="HF265A80BCACD4732BC6D39230588AEAA"><enum>(1)</enum><text>in section 502, by adding at the end the following:</text>
<quoted-block id="HA407A0B8BA5045FDAF2CBBC078F7DCA5">
<subsection id="H5D1B4F4B9C76461FA071C43C26C02A3"><enum>(w)</enum><text>If it is a drug or biological product, unless it includes a unique product identifier for the drug or biological product as required by regulations under section 510(q).</text></subsection><after-quoted-block>; and</after-quoted-block></quoted-block></paragraph>
<paragraph id="H8B4BDF3EDC23496AAA64342434D14877"><enum>(2)</enum><text>in section 510, by adding at the end the following:</text>
<quoted-block id="HC5031D6F4C3D422791F46B305F83056D">
<subsection id="H8570940771024F4EBC399157BA6661A8"><enum>(q)</enum>
<paragraph display-inline="yes-display-inline" id="H0DD0E0FF8FD54DE1B5365F29A15574F"><enum>(1)</enum><text>The Secretary shall issue, and may periodically revise, regulations requiring the manufacturer of any drug or biological product that is subject to regulation by the Food and Drug Administration, or the packager or labeler of a drug or biological product that is subject to regulation by the Food and Drug Administration, to include a unique product identifier on the packaging of the drug or biological product.</text></paragraph>
<paragraph indent="subsection" id="HDCF38895D1734B8CA28991B227EAFE00"><enum>(2)</enum><text>For purposes of this subsection, the term <term>unique product identifier</term> means an identification that—</text>
<subparagraph indent="paragraph" id="H5946816E55294049BD06B5C42E45ECFE"><enum>(A)</enum><text>is affixed by the manufacturer, labeler, or packager to each drug or biological product described in paragraph (1) at each packaging level;</text></subparagraph>
<subparagraph indent="paragraph" id="HBB96FEF942CA4B63A05E5E73A2B8BBB4"><enum>(B)</enum><text>uniquely identifies the item and meets the standards required by this section; and</text></subparagraph>
<subparagraph indent="paragraph" id="H5F155DAF53124093963188380000729C"><enum>(C)</enum><text>can be read by a scanning device or other technology acceptable to the Secretary.</text></subparagraph></paragraph>
<paragraph indent="subsection" id="H8C118287716142B6862938970048F781"><enum>(3)</enum><text>A unique product identifier required by regulations issued or revised under paragraph (1) shall be based on—</text>
<subparagraph indent="paragraph" id="H7A82C1B1EBFC4451A96843C1CD8D8B62"><enum>(A)</enum><text>the National Drug Code maintained by the Food and Drug Administration;</text></subparagraph>
<subparagraph indent="paragraph" id="HEFE68E48DD2443E3A415B4A9312363C7"><enum>(B)</enum><text>commercially accepted standards established by organizations that are accredited by the American National Standards Institute, such as the Health Industry Business Communication Council or the Uniform Code Council; or</text></subparagraph>
<subparagraph indent="paragraph" id="HF0563461DC824F908C86FCEE2E8D581F"><enum>(C)</enum><text>other identification formats that the Secretary deems appropriate.</text></subparagraph></paragraph>
<paragraph indent="subsection" id="HD84E740E215945A3B52D68377925A08D"><enum>(4)</enum><text>The Secretary may, at the Secretary’s discretion, waive the requirements of this section, or add additional provisions that are necessary to safeguard the public health.</text></paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block></paragraph></section>
<section id="H0B7B8979D2E9423882BDECFE346F5518"><enum>104.</enum><header>Grants for electronic prescription programs</header>
<subsection id="H28FD29B6625E4D2D9F16949E53BE6D6E"><enum>(a)</enum><header>Grants</header>
<paragraph id="H83CD92C092C142A599A538D599006BB2"><enum>(1)</enum><header>In general</header><text>The Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) may make grants to qualified practitioners for the purpose of establishing electronic prescription programs.</text></paragraph>
<paragraph id="H96FB99C45995467EAE26D61E8DAFF59D"><enum>(2)</enum><header>Matching funds</header>
<subparagraph id="HD9C877723E274FC4A9EA00D0566D71A4"><enum>(A)</enum><header>In general</header><text>With respect to the costs of establishing an electronic prescription program, a condition for the receipt of a grant under paragraph (1) is that the qualified practitioner involved agree to make available (directly or through donations from public or private entities) non-Federal contributions toward such costs in an amount that is not less than 50 percent of such costs.</text></subparagraph>
<subparagraph id="HB182B8327870424400F11E88B586DB24"><enum>(B)</enum><header>Determination of amount contributed</header><text>Non-Federal contributions required in subparagraph (A) may be in cash or in kind, fairly evaluated, including equipment or services. Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.</text></subparagraph></paragraph></subsection>
<subsection id="HF4CA9C4153C341B39C1CDBA5494EEE84"><enum>(b)</enum><header>Study</header>
<paragraph id="H234665EC76BB49C4A718D0B53AECD45"><enum>(1)</enum><header>In general</header><text>The Secretary, acting through the Director of the Agency for Healthcare Research and Quality, shall support a study to assess existing scientific evidence regarding the effectiveness and cost-effectiveness of the use of electronic prescription programs intended to improve the efficiency of prescription ordering and the safe and effective use of prescription drugs. The study shall address the following:</text>
<subparagraph id="HD270416E6B974A21A56F29E74F466FCA"><enum>(A)</enum><text>The ability of such programs to reduce medical errors and improve the quality and safety of patient care.</text></subparagraph>
<subparagraph id="H137A3C5607C4405F96313791AF7BB3EC"><enum>(B)</enum><text>The impact of the use of such programs on physicians, pharmacists, and patients, including such factors as direct and indirect costs, changes in productivity, and satisfaction.</text></subparagraph>
<subparagraph id="H5CDBA132519B454BAFDCED98E49C7D55"><enum>(C)</enum><text>The effectiveness of strategies for overcoming barriers to the use of electronic prescription programs.</text></subparagraph></paragraph>
<paragraph id="H7CCAE772835A44B485C4EA0087508526"><enum>(2)</enum><header>Report</header><text>The Secretary shall ensure that, not later than 18 months after the date of the enactment of this Act, a report containing the findings of the study under paragraph (1) is submitted to the appropriate committees of the Congress.</text></paragraph>
<paragraph id="H49C2AA253CA640F8BD21799B9569EA25"><enum>(3)</enum><header>Dissemination of findings</header><text>The Secretary shall disseminate the findings of the study under paragraph (1) to appropriate public and private entities.</text></paragraph></subsection>
<subsection id="H7D11E62C55E4476CAE4DC7EBA6D46C8"><enum>(c)</enum><header>Development of model</header><text>The Secretary, acting through the Director of the Agency for Healthcare Research and Quality, may develop an Internet-based mathematical model that simulates the cost and effectiveness of electronic prescription programs for qualified practitioners. The model may be designed to allow qualified practitioners to estimate, through an interactive interface, the impact of electronic prescribing on their practices, including the reduction in drug-related health care errors.</text></subsection>
<subsection id="H6EF64EFA557743FFBDBC50071F12C88"><enum>(d)</enum><header>Definitions</header><text>For purposes of this section:</text>
<paragraph id="H7818F5F8CAB845759D9D2BBA8F172B47"><enum>(1)</enum><text>The term <term>electronic prescription program</term>—</text>
<subparagraph id="HA3939216AF5145D78505930854B6D6C2"><enum>(A)</enum><text>means a program for the electronic submission and processing of prescriptions; and</text></subparagraph>
<subparagraph id="H430667BB988C40A59436A20900F948B1"><enum>(B)</enum><text>includes the hardware (including computers and other electronic devices) and software programs for the electronic submission of prescriptions to pharmacies, the processing of such submissions by pharmacies, and decision-support programs.</text></subparagraph></paragraph>
<paragraph id="HF39A511546614D68BCC5AB4EFC3CA76E"><enum>(2)</enum><text>The term <term>qualified practitioner</term> means a practitioner licensed by law to administer or dispense prescription drugs.</text></paragraph></subsection></section>
<section id="HF79B24808B734DD5AD9300A277D4CCB"><enum>105.</enum><header>Grants to hospitals and other health care providers for information technologies</header>
<subsection id="H2902BB874D2844D58BF045D7C6A0561F"><enum>(a)</enum><header>In general</header><text>The Secretary of Health and Human Services (in this section referred to as the <quote>Secretary</quote>) shall make grants to hospitals and other health care providers (but not more than 1 grant to any 1 hospital or provider) to pay the costs of acquiring or implementing information technologies whose purposes are—</text>
<paragraph id="H75EBE92BD7034FFEAAF9A49564AD115F"><enum>(1)</enum><text>to improve quality of care and patient safety; and</text></paragraph>
<paragraph id="H946574086E3A4D9997AF52792E2680DE"><enum>(2)</enum><text>to reduce adverse events and health care complications resulting from medication errors.</text></paragraph></subsection>
<subsection id="HEAEAC66E7BF248349E351E63DE9EDC7"><enum>(b)</enum><header>Special consideration</header><text>In making grants under subsection (a), the Secretary shall give special consideration to applicants who seek to promote the following:</text>
<paragraph id="H374A7D549D04498492E5D8706EAF73E8"><enum>(1)</enum><text>Interoperability across hospital services or departments using standards developed or adopted by the Secretary under section 102.</text></paragraph>
<paragraph id="H8B0B8A695CA44124BEDC55E0CAD14C6"><enum>(2)</enum><text>Electronic communication of patient data across the spectrum of health care delivery.</text></paragraph>
<paragraph id="HF6BC07C391B447EDA0835074C0FF5777"><enum>(3)</enum><text>Computerized physician order entry or bar coding applications.</text></paragraph>
<paragraph id="HC82EA6F3C43440C08CEFE01E91A5CCA1"><enum>(4)</enum><text>Electronic communication of patient data in hospitals that provide services to underserved or low-income populations.</text></paragraph>
<paragraph id="H63DF97EB47784222B853820031D886B9"><enum>(5)</enum><text>Improved clinical decisionmaking through acquisition and implementation of decision-support technologies.</text></paragraph></subsection>
<subsection id="H9D5D5A7823784659B73E941F00B033E3"><enum>(c)</enum><header>Certain grant conditions</header><text>A condition for the receipt of a grant under subsection (a) is that the applicant involved meet the following requirements:</text>
<paragraph id="H3E6D1234490A4526B8E748EC288FBC98"><enum>(1)</enum><text>The applicant agrees to carry out a program to measure, analyze, and report patient safety and medical errors at the hospital or other health care provider involved, to submit to the Secretary a description of the methodology that will be used, and to have such program in effect as soon as practicable after the application for the grant is approved, without regard to whether information technologies under the grant have been implemented.</text></paragraph>
<paragraph id="H8D3F00C5EA574B5DB44E65243D4D2700"><enum>(2)</enum><text>The applicant has arranged for an evaluation that addresses the effectiveness and cost-effectiveness of the information technology for which the grant is provided and its impact on the quality and safety of patient care, submitted the evaluation plan to the Secretary, and received approval from the Secretary of the applicant’s methodology.</text></paragraph>
<paragraph id="HE3871270F6114CF7A3EEE696A5241135"><enum>(3)</enum><text>The applicant has or is developing a patient safety evaluation system (as that term is defined in section 921 of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name> (as amended by section 101)) for reporting health care errors to a patient safety organization.</text></paragraph>
<paragraph id="HE5B559B46A444FE5B93581FAB148E261"><enum>(4)</enum><text>The applicant agrees to provide the Secretary with such information as the Secretary may require regarding the use of funds under this program or its impact.</text></paragraph>
<paragraph id="H2E00A5764330479FB8DD7416C304897"><enum>(5)</enum><text>The applicant provides assurances satisfactory to the Secretary that any information technology planned, acquired, or implemented with grant funds under this section will be part of an information program that—</text>
<subparagraph id="HC705AB7160994CFC834E55314717A001"><enum>(A)</enum><text>carries out the purposes described in subsection (a); and</text></subparagraph>
<subparagraph id="H6F3F5D6673ED47C58956F1076A2F244"><enum>(B)</enum><text>is comprehensive or will be expanded to become comprehensive, regardless of whether Federal assistance is available for such expansion.</text></subparagraph></paragraph></subsection>
<subsection id="H49C288334BC74E8E85F29390EF46F018"><enum>(d)</enum><header>Technical assistance to grantees</header><text>The Secretary, acting through the Director of the Agency for Healthcare Research and Quality, shall provide technical assistance to applicants and grantees to ensure the appropriate evaluation of the information technologies for which grants are awarded under this section, such as—</text>
<paragraph id="HEE469A0A3CFC47C6A99F69CD2E2EACDB"><enum>(1)</enum><text>reviewing and providing technical assistance on the applicant’s proposed evaluation;</text></paragraph>
<paragraph id="HAED9F2F7277D44FD88E1E200D4677CC2"><enum>(2)</enum><text>developing mechanisms to ensure ongoing communications between grantees and evaluators to facilitate the identification and resolution of problems as they arise, ensure mutual learning, and promote the rapid dissemination of information;</text></paragraph>
<paragraph id="H5ECF76520CAF4DF29FDE89986D8284AC"><enum>(3)</enum><text>reviewing the interim and final reports required under subsection (e); and</text></paragraph>
<paragraph id="HB87B9AEA25BB491AACC9412E24CDDA2F"><enum>(4)</enum><text>disseminating evidence-based information in interim and final reports to patient safety organizations, as appropriate.</text></paragraph></subsection>
<subsection id="H1B8608D73FA141169247C766E129DF27"><enum>(e)</enum><header>Evaluation reports by grantee</header><text>A condition for the receipt of a grant under subsection (a) is that the applicant agree to submit an interim and a final report to the Secretary in accordance with this subsection.</text>
<paragraph id="H3C7397F16A5B4250B55B00839DE5AF81"><enum>(1)</enum><header>Interim report</header><text>Not later than 1 year after the implementation of information technologies under the grant is completed, the applicant will submit an interim report to the Secretary describing the initial effectiveness of such technologies in carrying out the purposes described in subsection (a).</text></paragraph>
<paragraph id="HBED4F11608B14BFF8507CACBA0226D18"><enum>(2)</enum><header>Final report</header><text>Not later than 3 years after the implementation of information technologies under the grant is completed, the applicant will submit a final report to the Secretary describing the effectiveness and cost-effectiveness of such technologies and addressing other issues determined to be important in carrying out the purposes described in subsection (a).</text></paragraph>
<paragraph id="HCECE2568A65042EEBFA9843C1F4FA000"><enum>(3)</enum><header>Relation to disbursement of grant</header><text>In disbursing a grant under subsection (a), the Secretary shall withhold <fraction>1/3</fraction> of the grant until the grantee submits to the Secretary the report required in paragraph (1).</text></paragraph></subsection>
<subsection id="H0596868877574A16A61453F029A53FA9"><enum>(f)</enum><header>Reports by Secretary</header>
<paragraph id="HC3E7F29CFEA84015BB25BA5CBFF1A367"><enum>(1)</enum><header>Interim reports</header>
<subparagraph id="H7CD3AE79C7D24929B2EE566FF31F216F"><enum>(A)</enum><header>In general</header><text>Through the fiscal year preceding the fiscal year in which the final report under paragraph (2) is prepared, the Secretary shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate periodic reports on the grant program under subsection (a). Such reports shall be submitted not less frequently than once each fiscal year, beginning with fiscal year 2004.</text></subparagraph>
<subparagraph id="H2D8E80423CDA4C899F1D8E39BB6F81B2"><enum>(B)</enum><header>Contents</header><text>A report under subparagraph (A) shall include information on—</text>
<clause id="H756405CC936C4863A58264684F3395E4"><enum>(i)</enum><text>the number of grants made;</text></clause>
<clause id="HE858FBB2859D4704ACA1319202005C15"><enum>(ii)</enum><text>the nature of the projects for which funding is provided under the grant program;</text></clause>
<clause id="HA0081192C8FC458BA649B91727231227"><enum>(iii)</enum><text>the geographic distribution of grant recipients; and</text></clause>
<clause id="H9F39A02AE89A4362AE135BA826C77335"><enum>(iv)</enum><text>such other matters as the Secretary determines appropriate.</text></clause></subparagraph></paragraph>
<paragraph id="HC47A3D0DA9804D17B04C61EBFD18DB57"><enum>(2)</enum><header>Final report</header><text>Not later than 180 days after the date on which the last of the reports is due under subsection (e)(2), the Secretary shall submit a final report to the committees referred to in paragraph (1)(A) on the grant program under subsection (a), together with such recommendations for legislation and administrative action as the Secretary determines appropriate.</text></paragraph></subsection>
<subsection id="H46FA2782CF504863BCB753E9618B5F05"><enum>(g)</enum><header>Definitions</header><text>For purposes of this section:</text>
<paragraph id="H944CE2FE8A19493C9EF9B16A48FFEC3"><enum>(1)</enum><text>The term <term>costs</term>, with respect to information technologies referred to in subsection (a), includes total expenditures incurred for—</text>
<subparagraph id="HDFA9BE258595439D8300A42C3522D143"><enum>(A)</enum><text>purchasing, leasing, and installing computer software and hardware, including hand-held computer technologies;</text></subparagraph>
<subparagraph id="H1C77DF55776C49ED979DF68D883B2FCD"><enum>(B)</enum><text>making improvements to existing computer software and hardware; and</text></subparagraph>
<subparagraph id="H39DDFFC003B14771A8D537D632F9DEC6"><enum>(C)</enum><text>purchasing or leasing communications capabilities necessary for clinical data access, storage, and exchange.</text></subparagraph></paragraph>
<paragraph id="HCC472B2E1B0E4CA4B5066E9148003C44"><enum>(2)</enum><text>The term <term>health care provider</term> has the same meaning given to the term <term>provider</term> in section 921 of the Public Health Services Act (as amended by this Act).</text></paragraph></subsection>
<subsection id="HE0A60431E0674E639496C3429CAD3600"><enum>(h)</enum><header>Termination of grant authorities</header><text>The authority of the Secretary to make grants under subsection (a) terminates upon the expiration of fiscal year 2013.</text></subsection>
<subsection id="H2722D18ED6324EC4ADD619DD90976B2F"><enum>(i)</enum><header>Matching funds</header>
<paragraph id="H7E67EF5A9BD841BC945704A84FCB3A6"><enum>(1)</enum><header>In general</header><text>With respect to the costs of a grant to be carried out under this section, such grant may be made only if the applicant agrees to make available (directly or through donations from public or private entities) non-Federal contributions toward such costs in an amount that is not less than 50 percent of such costs ($1 for each $1 of Federal funds provided in the grant).</text></paragraph>
<paragraph id="H7D10ED093DA74D60B0F5DC4B7D5568B8"><enum>(2)</enum><header>Determination of amounts contributed</header><text>Amounts provided by the Federal Government, or services assisted or subsidized to any significant extent by the Federal Government, may not be included in determining the amount of such non-Federal contributions.</text></paragraph></subsection></section>
<section id="H07A2A0BF08474B2E821EEC2938A28221"><enum>106.</enum><header>Authorization of appropriations for grants under sections 104 and 105</header><text display-inline="no-display-inline">For the purpose of carrying out sections 104 and 105, there are authorized to be appropriated $25,000,000 for each of fiscal years 2006 and 2007.</text></section>
<enum>II</enum><header>Medical Information Technology Advisory Board</header>
<section id="HF422DEF0C01944A28ECE0847229F17F2"><enum>201.</enum><header>Medical Information Technology Advisory Board</header><text display-inline="no-display-inline">Title XI of the <act-name parsable-cite="SSA">Social Security Act</act-name> is amended by adding at the end the following new section:</text>
<quoted-block act-name="Social Security Act" style="other" other-style="archaic" id="HDD7DAFB6FC994D65A9B043DDCA532031">
<section id="H933FE1A84D0F430B94200694B24EA3F2"><enum>1180.</enum><header>Medical Information Technology Advisory Board</header>
<subsection display-inline="yes-display-inline" id="H0322AC2B29D04E148D1BD1618D33EF4F"><enum>(a)</enum><header>Establishment</header>
<paragraph id="H7AE914B64B7F4A70BCFFDACF69003969"><enum>(1)</enum><header>In general</header><text>Not later than 3 months after the date of the enactment of this section, the Secretary shall appoint an advisory board to be known as the <quote>Medical Information Technology Advisory Board</quote> (in this section referred to as the <quote>MITAB</quote>).</text></paragraph>
<paragraph id="H339CA3AF73934715928540C5BFEC8200"><enum>(2)</enum><header>Chairman</header><text>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.</text></paragraph></subsection>
<subsection id="HD02021C9A84B4F35A3FD68D785797D9F"><enum>(b)</enum><header>Composition</header>
<paragraph id="H687ACE1957C940C4A0C8FB952429D13"><enum>(1)</enum><header>In general</header><text>The MITAB shall consist of not more than 17 members that include—</text>
<subparagraph id="H48EF6627E8E24412AD99ECB400195FD9"><enum>(A)</enum><text>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;</text></subparagraph>
<subparagraph id="H2DB32F3BEF4A450299036B68A3CC9B34"><enum>(B)</enum><text>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;</text></subparagraph>
<subparagraph id="H710D871C6BE74FDA9B374FC9498DEA4B"><enum>(C)</enum><text>representatives of private organizations with expertise in medical infomatics;</text></subparagraph>
<subparagraph id="HE828422E6D3C43769935B6C412E6FD9C"><enum>(D)</enum><text>a representative of a teaching hospital; and</text></subparagraph>
<subparagraph id="H0DE439B191C747FE9E6FF1FCDC6D1F6"><enum>(E)</enum><text>one or more representatives of the health care information technology industry.</text></subparagraph></paragraph>
<paragraph id="H46E11EC2A19C4A07948C5B99ABE436B"><enum>(2)</enum><header>Terms of appointment</header><text>The term of any appointment under paragraph (1) to the MITAB shall be for the life of the MITAB.</text></paragraph>
<paragraph id="H54BA032568CC46288200D02513460011"><enum>(3)</enum><header>Meetings</header><text>The MITAB shall meet at the call of its chairman or a majority of its members.</text></paragraph>
<paragraph id="H7D75F5FC2A0D49C3B8C51C388DBC8F26"><enum>(4)</enum><header>Vacancies</header><text>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.</text></paragraph>
<paragraph id="H88B095196C0940CBB0A4753044F5B381"><enum>(5)</enum><header>Compensation</header><text>Members of the MITAB shall receive no additional pay, allowances, or benefits by reason of their service on the MITAB.</text></paragraph>
<paragraph id="H2FC91B950A63417500716CD3007DDEFA"><enum>(6)</enum><header>Expenses</header><text>Each member of the MITAB shall receive travel expenses and per diem in lieu of subsistence in accordance with sections <external-xref legal-doc="usc" parsable-cite="usc/5/5702">5702</external-xref> and <external-xref legal-doc="usc" parsable-cite="usc/5/5703">5703</external-xref> of title 5, United States Code.</text></paragraph></subsection>
<subsection id="H7CFE2FC26DD743C3BBCEA1D362422FC"><enum>(c)</enum><header>Duties</header>
<paragraph id="H01E0E33B468046E8AE25402FBA180383"><enum>(1)</enum><header>In general</header><text>The MITAB shall on an ongoing basis advise, and make recommendations to, the Secretary regarding medical information technology, including the following:</text>
<subparagraph id="H32552520D49D4D80BF5838BD6EED06F2"><enum>(A)</enum><text>The best current practices in medical information technology.</text></subparagraph>
<subparagraph id="H4E62CEC3D96C467D91CC9C409EA0D697"><enum>(B)</enum><text>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.</text></subparagraph>
<subparagraph id="H77DE6043B9F548B58FAD67E714E9596F"><enum>(C)</enum><text>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).</text></subparagraph>
<subparagraph id="H79B31DF36A1C4EED94FA1CB79DE7D3EB"><enum>(D)</enum><text>Methods of implementing—</text>
<clause id="H5A82944EDBB54E9E9E6D1D9C99745B78"><enum>(i)</enum><text>health care information technology interoperability standardization; and</text></clause>
<clause id="HF20F2EE3EA9F42B7A240009230543835"><enum>(ii)</enum><text>records security.</text></clause></subparagraph>
<subparagraph id="H5A25912BE95D4DBBAD063050D68409D"><enum>(E)</enum><text>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:</text>
<clause id="H189D87B7264D420E845950B0AB81C508"><enum>(i)</enum><text>To maximize positive outcomes in clinical care—</text>
<subclause id="H21594A10B8C143B5A750B9D283A01F00"><enum>(I)</enum><text>by providing decision support for diagnosis and care; and</text></subclause>
<subclause id="HC5F83876DDD54427B100C9329CFB2E71"><enum>(II)</enum><text>by assisting in the emergency treatment of a patient presenting at a facility where there is no medical record for the patient.</text></subclause></clause>
<clause id="HE62C3B98E4F74433A41BE259523ED79B"><enum>(ii)</enum><text>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.</text></clause>
<clause id="H9F17D69E2C944C359640B9B894427A0"><enum>(iii)</enum><text>To reduce or eliminate the need for redundant records, paperwork, and the repetitive taking of patient histories and administering of tests.</text></clause>
<clause id="H6FB375AAEB39439300C9003CCC45BD5D"><enum>(iv)</enum><text>To minimize medical errors, such as administration of contraindicated drugs.</text></clause>
<clause id="H5E2E218CABC14217A5A9DA00CE958F97"><enum>(v)</enum><text>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.</text></clause></subparagraph></paragraph>
<paragraph id="HF3E9B1B78C1245C7897181A9C9CCDFF5"><enum>(2)</enum><header>Reports</header>
<subparagraph id="H86C81C693F8341F7885DB03DC44BE351"><enum>(A)</enum><header>Initial report</header><text>No later than 18 months after the date of the enactment of this section, the MITAB shall submit to Congress and the Secretary an initial report concerning the matters described in paragraph (1). The report shall include—</text>
<clause id="H0105C216B2554A1BB19C7300453F8279"><enum>(i)</enum><text>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;</text></clause>
<clause id="HAB4BE00BC2A8424EBBD511EC84689786"><enum>(ii)</enum><text>recommendations for accelerating the development of common health care terminology standards;</text></clause>
<clause id="HFA5B726E424F47FF93688273CCE924E6"><enum>(iii)</enum><text>recommendations for completing development of health care information system messaging standards; and</text></clause>
<clause id="H9483050903844F0EADAB92C754A8F8C1"><enum>(iv)</enum><text>progress toward meeting the deadline described in paragraph (1)(B) for adoption of methods described in such paragraph.</text></clause></subparagraph>
<subparagraph id="H4E4F3CD71903432EA0229D79E0F33B76"><enum>(B)</enum><header>Subsequent reports</header><text>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 102 of the Patient Safety and Quality Improvement Act, and such other matters as may help ensure the most rapid dissemination of best practices in health care information technology.</text></subparagraph></paragraph></subsection>
<subsection id="H1B68C1350B554968A0AC05F52D3C6826"><enum>(d)</enum><header>Staff and support services</header>
<paragraph id="HB8B23A7A4E4A48FB9BA448F35650DCA6"><enum>(1)</enum><header>Executive Director</header>
<subparagraph id="H2F26CB62BED14B1089DD7E2233D515C3"><enum>(A)</enum><header>Appointment</header><text>The Chairman shall appoint an executive director of the MITAB.</text></subparagraph>
<subparagraph id="H0F275E86C34C4555B37447087407DFB4"><enum>(B)</enum><header>Compensation</header><text>The executive director shall be paid the rate of basic pay for level V of the Executive Schedule.</text></subparagraph></paragraph>
<paragraph id="H73D5DE872C234261AAF900B94E33D138"><enum>(2)</enum><header>Staff</header><text>With the approval of the MITAB, the executive director may appoint such personnel as the executive director considers appropriate.</text></paragraph>
<paragraph id="H9F2C3820935D4CC6AE013F36F351F195"><enum>(3)</enum><header>Applicability of civil service laws</header><text>The staff of the MITAB shall be appointed without regard to the provisions of title 5, United States Code, governing 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).</text></paragraph>
<paragraph id="H2D6F0117AE2642649BDBB119D800DA8B"><enum>(4)</enum><header>Experts and consultants</header><text>With the approval of the MITAB, the executive director may procure temporary and intermittent services under <external-xref legal-doc="usc" parsable-cite="usc/5/3109">section 3109(b)</external-xref> of title 5, United States Code.</text></paragraph></subsection>
<subsection id="H873AB9CBD13E41DDB5863350003E1439"><enum>(e)</enum><header>Powers</header>
<paragraph id="H98E94E2F8D244C09A692256F132BAC66"><enum>(1)</enum><header>Hearings and other activities</header><text>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.</text></paragraph>
<paragraph id="H078BA8E14ED640488E7745E87A22EA3"><enum>(2)</enum><header>Detail of Federal employees</header><text>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.</text></paragraph>
<paragraph id="HD37EC34EAA7C4F32ADBB4EF376C0D3E1"><enum>(3)</enum><header>Technical assistance</header><text>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.</text></paragraph>
<paragraph id="HC0C095A3E7254DF88FE323E022F0E7B"><enum>(4)</enum><header>Obtaining information</header><text>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 <external-xref legal-doc="usc" parsable-cite="usc/5/552">section 552</external-xref> 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.</text></paragraph></subsection>
<subsection id="HDD11404653994BE5AC902FEED900276F"><enum>(f)</enum><header>Termination</header><text>The MITAB shall terminate 30 days after the date of submission of its final report under subsection (c)(2)(B).</text></subsection>
<subsection id="H25053104B5364F1EB0FD61C2FAB3E988"><enum>(g)</enum><header>Applicability of FACA</header><text>The provisions of the <act-name parsable-cite="FACA">Federal Advisory Committee Act</act-name> (5 U.S.C. App.) shall apply to the MITAB.</text></subsection>
<subsection id="H54680313607641C28115A5F2FE6F04FD"><enum>(h)</enum><header>Funding</header><text>There are authorized to be appropriated such sums as are necessary for each fiscal year to carry out this section.</text></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block></section>