,,ii #aahth ,,congress #b;d ,session ,s4 #efac ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,december #ai 7legislative day1 ,december #af71 #bjbd,mr4 ,van ,hollen 7for himself and ,mr4 ,lujn7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to improve the quality1 appropriateness1 and effectiveness of diagnosis in health care1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,improving ,diagnosis in ,medicine ,act of #bjbb4 #b4 ,research program to improve diagnostic safety and quality ,part ,b of title ,,ix of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b et seq47 is amended by adding at the end the following3 #iah4 ,research program to improve diagnostic safety and quality 7a7 ,in general ,the ,director shall establish a comprehensive program of research and quality improvement to-- 7#a7 assess and understand diagnostic errors1 including diagnostic delays1 and how to eliminate common failures in the diagnostic process that lead to significant patient harm2 and 7#b7 identify1 develop1 implement1 and disseminate evidence-based strategies and best practices for improving diagnostic quality1 safety1 and health care value4 7b7 ,activities ,the program established under subsection 7a7 shall include the following3 7#a7 ,continuum of research ,a portfolio of conducted and supported activities that is consistent with the general1 research1 implementation1 and dissemination activities of the ,center for ,quality ,improvement and ,patient ,safety1 as described in section #icc1 including-- 7,a7 investigator-initiated research to assess diagnostic errors and identify improved methods to prevent errors and the harm they cause2 7,b7 translation and synthesis of research findings and development of tools for implementing prevention strategies into practice2 7,c7 implementation research to refine evidence-based tools for improving diagnostic processes and effectively integrate these solutions into practice2 and 7,d7 dissemination to promote implementation of effective methods1 strategies and tools for wide-scale improvement4 7#b7 ,research centers of diagnostic excellence ,consistent with section #iaa7;b71 such ,centers shall link research directly with clinical practice in geographically diverse locations throughout the ,united ,states1 and may include-- 7,a7 academic medical and institutional research centers that combine demonstrated multidisciplinary expertise in diagnostic outcomes or quality improvement research with linkages directly or through national1 state or local stakeholder partner organizations to relevant sites of care2 7,b7 provider-based research networks1 including plan1 facility1 or delivery system sites of care 7especially primary care71 that can evaluate outcomes and evaluate and promote quality improvement approaches4 7#c7 ,financial assistance ,the ,director may provide financial assistance to assist in meeting the costs of planning and establishing new centers1 as well as operating existing and new centers1 pursuant to section #ijb7;c74 7#d7 ,stakeholder engagement ,the ,director shall identify and enter into a supporting agreement 7grant or contract7 with a nonprofit entity that convenes a coalition of diverse health care stakeholders for the purpose of-- 7,a7 raising attention to diagnostic safety and quality concerns2 7,b7 facilitating learning1 adoption and spread of effective quality improvement interventions2 and 7,c7 catalyzing novel actions by individual member organizations to reduce harms from diagnostic error and improve patient outcomes4 7c7 ,authorization of appropriations 7#a7 ,in general ,to carry out this section1 there is authorized to be appropriated #bj1jjj1jjj for fiscal year #bjbc1 #be1jjj1jjj for fiscal year #bjbd1 #cj1jjj1jjj for fiscal year #bjbe1 and #ce1jjj1jjj for each of fiscal years #bjbf and #bjbg4 7#b7 ,reservation ,of the amount appropriated under paragraph 7#a7 for a fiscal year1 #gjj1jjj shall be allocated to carrying out the purpose described in subsection 7b77#d74 7#c7 ,availability ,amounts appropriated under this section shall remain available until expended4 4 #c4 ,fellowships and training grants 7a7 ,ruth ,kirschstein awards ,section #dhg7;a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhh7;a77 is amended by adding at the end the following3 7#e7 ,for purposes of the program under this subsection1 biomedical and behavioral research includes diagnostic safety and quality research4 4 7b7 ,,ahrq programs ,section #ijb7;b77#a7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;a7b77#a77 is amended-- 7#a7 by inserting and diagnostic safety and quality after subsection 7a72 and 7#b7 by striking under section #dhg7;d77#c7 and inserting for purposes of carrying out section #dhg4 #d4 ,quality measure development ,section #ica7;c77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b-#ca7;c77#b77 is amended-- 7#a7 by redesignating subparagraphs 7,b7 through 7,j7 as subparagraphs 7,c7 through 7,k71 respectively2 and 7#b7 by inserting after subparagraph 7,a7 the following3 7,b7 diagnostic safety and quality2 4 #e4 ,data for research and improvement ,section #icg7;f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b-#cg7;f77 is amended-- 7#a7 by striking ,the ,secretary and inserting the following3 7#a7 ,in general ,the ,secretary 2 and 7#b7 adding at the end the following3 7#b7 ,consultation with expert panel ,in carrying out paragraph 7#a71 the ,secretary1 in coordination with the ,director1 the ,director of the ,centers for ,medicare ,medicaid ,services1 the ,national ,coordinator for ,health ,information ,technology1 and the ,national ,library of ,medicine1 shall convene an expert panel to consider and make recommendations regarding the types1 sources1 and availability of data needed to accelerate diagnostic safety and quality research1 training1 and measure development as specified in section #iah1 including data related to racial1 ethnic1 and language attributes2 gender1 age1 geography1 and socioeconomic conditions2 the specificity1 interoperability1 and socio-technical aspects of electronic vocabularies and ontologies related to presenting symptoms and diagnostic certainty2 and the development and use of symptom-based clinical registries4 ,such panel shall consider enhanced data capabilities that are necessary to support both research and improvement of diagnostic safety and quality4 4 #f4 ,interagency ,council on ,improving ,diagnosis in ,health ,care 7a7 ,establishment ,the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall establish within the ,office of the ,secretary an interagency council to be known as the ,interagency ,council on ,improving ,diagnosis in ,health ,care 7referred to in this section as the ,council74 7b7 ,objectives ,the objectives of the ,council shall be the following3 7#a7 ,enhance the quality1 appropriateness1 and effectiveness of diagnosis in health care through-- 7,a7 the establishment and support of a broad base of scientific research2 7,b7 the dissemination and implementation of the results of such research2 and 7,c7 the promotion of improvements in clinical and health system practices4 7#b7 ,identify and eliminate systemic barriers to supporting research in improving diagnosis in health care4 7#c7 ,identify knowledge gaps1 research and data needs1 and opportunities congruent with agency missions to strengthen the clinical and translational research pipeline to improve diagnostic safety and quality1 including potential collaborative research initiatives among #b or more agencies1 offices1 institutes1 or centers within the ,department of ,health and ,human ,services or other ,federal agencies or offices4 7c7 ,membership 7#a7 ,chairperson ,the ,director of the ,agency for ,healthcare ,research and ,quality 7or the ,director's designee7 shall be the ,chairperson of the ,council4 7#b7 ,members 7,a7 ,in general ,in addition to the ,chairperson1 the ,council shall be comprised of the following3 7i7 ,at least #a designee from each of the following1 appointed by the head of the applicable department or agency3 7,i7 ,the ,centers for ,disease ,control and ,prevention4 7,,ii7 ,the ,centers for ,medicare ,medicaid ,services4 7,,iii7 ,the ,department of ,veterans ,affairs4 7,,iv7 ,the ,congressionally ,directed ,medical ,research ,program of the ,department of ,defense4 7,v7 ,the ,office of the ,national ,coordinator for ,health ,information ,technology4 7ii7 ,designees from the ,national ,institutes of ,health1 including a least #a designee from each of the following3 7,i7 ,the ,national ,cancer ,institute4 7,,ii7 ,the ,national ,center for ,advancing ,translational ,sciences4 7,,iii7 ,the ,national ,institute of ,allergy and ,infectious ,diseases4 7,,iv7 ,the ,national ,heart1 ,lung1 and ,blood ,institute4 7,v7 ,the ,national ,institute of ,neurological ,disorders and ,stroke4 7,,vi7 ,the ,national ,library of ,medicine4 7,,vii7 ,the ,national ,institute on ,minority ,health and ,health ,disparities4 7,,viii7 ,the ,national ,institute of ,nursing ,research4 7,,ix7 ,the ,eunice ,kennedy ,shriver ,national ,institute of ,child ,health and ,human ,development4 7iii7 ,designees from such other national research institutes and national centers as may be appropriate1 as determined by the ,director of the ,national ,institutes of ,health4 7,b7 ,additional members ,in addition to the designees under subparagraph 7,a71 the ,council may include such other designees from ,federal departments or agencies as the ,chairperson of the ,council deems appropriate4 7,c7 ,designation ,a person appointed to the ,council as a designee shall be a senior official or employee of the department or agency whose responsibilities and subject matter expertise are relevant to the ,council's objectives listed in subsection 7b71 as determined by the designating official4 7d7 ,strategic plan2 reports 7#a7 ,strategic ,federal ,plan to ,improve ,diagnosis in ,health ,care ,not later than #ah months after the date of enactment of this ,act1 the ,council shall develop1 submit to the ,secretary and ,congress1 and make publicly available a strategic plan1 to be known as the ,strategic ,federal ,plan to ,improve ,diagnosis1 that1 consistent with the objectives listed in subsection 7b7-- 7,a7 identifies coordinated opportunities to enhance scientific research and reduce systemic barriers in order to improve diagnosis in health care2 and 7,b7 includes legislative and administrative policy recommendations1 including opportunities to remove barriers to1 and enhance1 inter-agency coordination in the planning1 conduct1 and funding of1 such research4 7#b7 ,reports to ,congress ,not later than ,july #ca of every odd-numbered year beginning with the first such year after the date of submission of the first ,strategic ,federal ,plan to ,improve ,diagnosis under paragraph 7#a71 the ,council shall prepare1 submit to the ,secretary and ,congress1 and make publicly available an updated ,strategic ,federal ,plan to ,improve ,diagnosis that includes-- 7,a7 such updates as the ,council determines to be appropriate2 7,b7 information on the overall progress of the ,federal ,government in reducing barriers to research on1 and supporting projects to improve1 diagnosis in health care2 and 7,c7 legislative and administrative policy recommendations1 including addressing any needs for greater legislative authority to meet the objectives listed in subsection 7b74 7e7 ,authorization of appropriations ,to carry out this section1 there are authorized to be appropriated #a1ejj1jjj for each of fiscal years #bjbc through #bjbg4 #g4 ,national academies report 7a7 ,in general ,the ,director of the ,agency for ,healthcare ,research and ,quality shall seek to enter into a contract with the ,national ,academies of ,sciences1 ,engineering1 and ,medicine under which such ,national ,academies conducts a study and issues a report on disparities in diagnostic safety and quality that-- 7#a7 identifies what is known about the burden and causes of such disparities1 including racial1 ethnic1 socioeconomic1 age1 gender1 geography1 language proficiency1 and intersectional interactions2 and 7#b7 includes recommendations on specific actions that policymakers1 researchers1 clinicians1 and other stakeholders can take to eliminate such burdens4 7b7 ,authorization of appropriations ,to carry out this section1 there is authorized to be appropriated #a1ejj1jjj for fiscal year #bjbc1 to remain available until expended4