,,ii #aadth ,,congress #b;d ,session ,s4 #bdfg ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,january #bg1 #bjaf ,mr4 ,whitehouse introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to reduce health care-associated infections and improve antibiotic stewardship through enhanced data collection and reporting1 the implementation of ,state-based quality improvement efforts1 and improvements in provider education in patient safety1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,patient ,safety ,improvement ,act of #bjaf4 #b4 ,findings ,congress finds the following3 7#a7 ,a #bjad prevalence survey published in the ,new ,england ,journal of ,medicine found that approximately #a in #be hospital patients in the ,united ,states has at least one health care-associated infection1 adding up to an estimated #gbb1jjj health care-associated infections in acute care hospitals in #bjaa4 ,about #ge1jjj hospital patients with health care-associated infections died during their hospitalizations4 7#b7 ,antibiotics are among the most commonly prescribed drugs used in human medicine4 ,studies indicate that up to #cj to #ej percent of antibiotics prescribed for patients are not needed or not optimally prescribed4 ,this is contributing to the growth in the prevalence of dangerous antibiotic-resistant bacteria4 7#c7 ,a #bjac threat report by the ,centers for ,disease ,control and ,prevention estimated that each year at least #b1jjj1jjj people in the ,united ,states are infected by antibiotic-resistant bacteria1 and approximately #bc1jjj die as a result4 7#d7 ,estimates of the annual impact of antibiotic-resistant infections on the ,united ,states economy vary but range from #bj1jjj1jjj1jjj to #ce1jjj1jjj1jjj in excess health care costs1 and as much as #ce1jjj1jjj1jjj in lost productivity from hospitalizations and sick days4 7#e7 ,the prevalence of health care-associated infections and the rise of antibiotic resistance are serious threats to human health and contribute to escalating health care costs4 ,strategies to reduce patient harm and preserve the effectiveness of existing antibiotics are needed to combat the rise of antibiotic resistance that is threatening the health of ,americans and people around the world4 #c4 ,improving data reliability and surveillance 7a7 ,reducing the incidence of health care-,associated infections and improving antibiotic stewardship 7#a7 ,in general ,subpart ,,ii of part ,d of title ,,ix of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b-#cc et seq47 is amended by adding at the end the following3 #ich4 ,health care-associated infections and antibiotic use 7a7 ,,gao study on data validation strategies 7#a7 ,in general ,not later than #a year after the date of enactment of this section1 the ,comptroller ,general of the ,united ,states shall conduct an independent evaluation1 and submit to the appropriate committees of ,congress a report1 concerning the action that the ,centers for ,disease ,control and ,prevention and ,state and local departments of health have taken to improve the completeness and accuracy of hospital-reported ,national ,healthcare ,safety ,network surveillance data4 7#b7 ,content ,the report submitted under paragraph 7#a7 shall review and assess-- 7,a7 the types of external and internal data validation strategies that are conducted by the ,centers for ,disease ,control and ,prevention1 ,state and local departments of health1 and hospitals2 7,b7 the frequency with which the ,centers for ,disease ,control and ,prevention1 ,state and local departments of health1 and hospitals audit data submitted to the ,national ,healthcare ,safety ,network2 and 7,c7 identify additional actions that the ,federal ,government can take to support ,state and local departments of health and hospitals with such validation efforts and improvements to the quality of data submitted to the ,national ,healthcare ,safety ,network4 7b7 ,data reliability framework 7#a7 ,in general ,following the submission of the report under subsection 7a71 the ,director of the ,centers for ,disease ,control and ,prevention1 in collaboration with the ,administrator of the ,agency for ,healthcare ,research and ,quality and relevant stakeholders1 shall develop a framework to improve the consistency and reliability of hospital data on health care-associated infections that is submitted to the ,national ,healthcare ,safety ,network4 7#b7 ,requirements ,the framework developed under paragraph 7#a7 shall-- 7,a7 address issues identified in the findings of the study conducted under subsection 7a72 7,b7 propose data validation and reliability methodologies2 and 7,c7 assess the effectiveness and the cost to implement proposed methodologies4 7c7 ,data collection pilot program 7#a7 ,in general ,the ,administrator of the ,agency for ,healthcare ,research and ,quality1 in collaboration with the ,director of the ,centers for ,disease ,control and ,prevention1 shall convene a meeting with relevant stakeholders to identify best practices and approaches for the collection and reporting of data on the incidence of health care-associated infections to the ,national ,healthcare ,safety ,network by long-term care facilities1 ambulatory surgical centers1 and dialysis facilities4 7#b7 ,pilot program ,after conducting the meeting under paragraph 7#a71 the ,administrator of the ,agency shall establish and implement a pilot program to test best practices and approaches for the collection and reporting of data on the incidence of health care-associated infections by long-term care facilities1 ambulatory surgical centers1 and dialysis facilities4 ,such pilot program should incorporate applicable data validation methodologies and other recommendations described in the framework developed under subsection 7b74 7#c7 ,report ,not later than #a year after the completion of the pilot program under paragraph 7#b71 the ,administrator shall submit to the ,secretary and the appropriate committees of ,congress a report on the best practices identified through the pilot program under paragraph 7#a71 including the lessons learned and challenges encountered with respect to data collection and reporting in long-term care settings1 ambulatory surgical centers1 and dialysis facilities as well as recommended data validation methods for those settings4 7#d7 ,authorization of appropriations ,there is authorized to be appropriated1 such sums as may be necessary to carry out this subsection4 ,amounts appropriated under the preceding sentence may be used for the purchase of software and technology that supports data collection and reporting4 4 #d4 ,aligning quality measures ,not later than #a year after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall solicit input from the ,administrator of the ,centers for ,medicare ,medicaid ,services1 the ,director of the ,centers for ,disease ,control and ,prevention1 an entity with the contract under section #ahij7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;aaa71 and relevant stakeholders 7including accreditation bodies7 concerning which definitions for health care-associated infections measures used in ,federal and ,state quality reporting and payment programs for hospitals1 long-term care facilities1 ambulatory surgical centers1 and dialysis centers should be aligned4 ,using such input1 the ,secretary shall submit a report to ,congress that identifies the following3 7#a7 ,priorities for measure alignment4 7#b7 ,programs in which the priority measures identified under paragraph 7#a7 are utilized4 7#c7 ,recommendations on how to implement the alignment of such measures4 #e4 ,reducing the incidence of health care-associated infections 7a7 ,in general ,part ,b of title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdc et seq47 is amended by adding at the end the following3 #cbj;,b4 ,efforts to reduce health care-associated infections 7a7 ,grant program ,to reduce health care-,associated infections 7#a7 ,in general ,the ,secretary shall award competitive grants to eligible entities to support ,state-based collaboratives in implementing evidence-based1 regional approaches to infection prevention1 control1 and surveillance4 7#b7 ,purpose ,amounts awarded under grants under paragraph 7#a7 may be used to support the following activities3 7,a7 ,inter-professional and inter-facility learning activities4 7,b7 ,building ,statewide learning collaboratives4 7,c7 ,assisting with the implementation of the transition-of-care documentation required in section #e of the ,patient ,safety ,improvement ,act of #bjaf4 7,d7 ,conducting a needs assessment to identify gaps in health care-associated infection prevention and reporting in a ,state or region4 7,e7 ,other activities determined appropriate by the ,secretary4 7#c7 ,eligibility ,to be eligible to receive a grant under this subsection1 an entity shall be a public or private nonprofit entity that submits to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary may require1 including-- 7,a7 a description of the activities to be carried out under the grant1 including the participants in any collaborative established to carry out such activities2 7,b7 goals for the reduction in regional or ,statewide rates of health care-associated infections2 7,c7 an assurance that the entity will publicly report performance on a set of quality and outcomes measures determined by the ,secretary2 and 7,d7 any other information determined appropriate by the ,secretary4 7#d7 ,priority ,in awarding grants under this subsection1 the ,secretary shall prioritize applicants that collaborate with multiple stakeholders across a region or ,state4 7#e7 ,authorization of appropriations ,there is authorized to be appropriated1 such sums as may be necessary to carry out this subsection4 4 7b7 ,improving communication of patient infections in ,medicare and ,medicaid 7#a7 ,medicare ,section #ahff7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc7a77 is amended-- 7,a7 in paragraph 7#a7-- 7i7 in subparagraph 7,x71 by striking and at the end2 7ii7 in subparagraph 7,y71 by striking the period at the end and inserting 1 and2 and 7iii7 by inserting after subparagraph 7,y7 the following new subparagraph3 7,z7 to comply with the requirement of paragraph 7#d7 7relating to the transmission of information regarding infections74 2 and 7,b7 by adding at the end the following new paragraph3 7#d7 7,a7 ,for purposes of paragraph 7#a77,z71 the requirement of this paragraph is that a hospital transmit information about infections or colonizations that present in an individual receiving treatment not later than #bd hours upon receipt of the culture to-- 7i7 the individual2 7ii7 in the case of an individual who is being transferred to another provider1 the receiving provider2 and 7iii7 the individual's primary care provider1 if identified4 7,b7 ,the information described in subparagraph 7,a7 shall contain the information fields included in the ,centers for ,disease ,control and ,prevention's ,inter-facility ,infection ,control ,transfer ,form and any other information the ,secretary determines appropriate4 7,c7 ,when transmitting information to a receiving provider under subparagraph 7,a77ii71 a provider shall1 where practical1 transmit such information electronically4 4 7#b7 ,medicaid ,section #aijb7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acif;a7a77 is amended-- 7,a7 in paragraph 7#hj71 by striking and at the end2 7,b7 in paragraph 7#ha71 by striking the period at the end and inserting 2 and2 and 7,c7 by inserting after paragraph 7#ha7 the following new paragraph3 7#hb7 in the case of any hospital 7as defined in section #ahfa7;e77 that is a participating provider under the ,state plan1 provide that such hospital meet the requirements of subparagraph 7,z7 of section #ahff7;a77#a74 4 7c7 ,standardized form ,not later than #f months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall issue a standardized electronic version of the form for use by providers in transmitting information as required by the amendments made by subsection 7b74 7d7 ,effective date 7#a7 ,medicare ,in the case of the requirements imposed by the amendments made by subsection 7b77#a71 such requirements shall apply to agreements entered into or renewed on or after the date that is #ahj days after the date of the issuance of the guidance described in subsection 7c74 7#b7 ,medicaid 7,a7 ,in general ,except as provided in subparagraph 7,b71 the requirements imposed by the amendments made by subsection 7b77#b7 shall take effect on the date that is #ahj days after the date of the issuance of the guidance described in subsection 7c74 7,b7 ,delay permitted if state legislation required ,in the case of a ,state plan for medical assistance under title ,,xix of the ,social ,security ,act which the ,secretary of ,health and ,human ,services determines requires ,state legislation 7other than legislation appropriating funds7 in order for the plan to meet the additional requirements imposed by subsection 7b77#b71 the ,state plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet these additional requirements before the first day of the first calendar quarter beginning after the close of the first regular session of the ,state legislature that begins after the date described in clause 7i74 ,for purposes of the previous sentence1 in the case of a ,state that has a #b-year legislative session1 each year of such session shall be deemed to be a separate regular session of the ,state legislature4 #f4 ,strengthening antibiotic stewardship 7a7 ,in general ,section #cbj;,b of the ,public ,health ,service ,act1 as added by section #e7;a71 is amended by adding at the end the following3 7b7 ,grant program for ,state antibiotic stewardship action plans 7#a7 ,in general ,the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall award grants to ,states for the development of ,state plans to promote antibiotic stewardship and prevent the spread of antimicrobial-resistant bacteria across health care settings4 7#b7 ,eligibility ,to be eligible to receive a grant under this subsection1 a ,state shall submit to the ,secretary an application at such time1 in such manner1 and containing such information as the ,secretary may require1 including-- 7,a7 an assurance that development of the plan under the grant will be led by an infectious-disease trained physician or a pharmacist with expertise in infectious disease2 and 7,b7 an assurance that the plan will focus on collaboration across acute and ambulatory care settings and include a summary of resource gaps and challenges4 7#c7 ,authorization of appropriations ,there is authorized to be appropriated1 such sums as may be necessary to carry out this subsection4 4 7b7 ,advancing hospital reporting on antibiotic use and antimicrobial resistance ,not later than ,january #a1 #bjah1 the ,administrator of the ,centers for ,medicare ,medicaid ,services shall require that acute care hospitals report antibiotic use and antimicrobial resistance using the ,national ,healthcare ,safety ,network's ,antimicrobial ,use and ,resistance ,module as part of the ,hospital ,inpatient ,quality ,reporting ,program4 7c7 ,information ,related to ,antibiotic ,use and ,antimicrobial ,resistance ,section #cbj;,b of the ,public ,health ,service ,act1 as added by section #e7;a7 and amended by subsection 7a71 is further amended by adding at the end the following3 7c7 ,information ,related to ,antibiotic ,use and ,antimicrobial ,resistance 7#a7 ,in general ,the ,director of the ,centers for ,disease ,control and ,prevention shall annually prepare and issue a report concerning the aggregate national and regional trends of antibiotic use and bacterial resistance in humans to antibacterial drugs1 including the identity of the #aj ,states with the highest number of prescriptions for antibiotics4 7#b7 ,stewardship workshops 7,a7 ,in general ,beginning on ,january #a1 #bjai1 and annually thereafter1 the ,director of the ,centers for ,disease ,control and ,prevention shall conduct at least one antibiotic stewardship workshop in a ,state identified in the report under paragraph 7#a74 7,b7 ,requirements ,the workshop under subparagraph 7,a7 shall identify regional strategies to support collaboration across the care continuum to promote antibiotic stewardship4 ,in implementing such workshop1 the ,director of the ,centers for ,disease ,control and ,prevention should seek participation from relevant public and private stakeholders with expertise in infection control1 quality improvement1 and consumer engagement4 7#c7 ,authorization of appropriations ,there is authorized to be appropriated1 such sums as may be necessary to carry out this subsection4 4 #g4 ,other improvements 7a7 ,in general ,section #cbj;,b of the ,public ,health ,service ,act1 as added by section #e7;a7 and amended by section #f7;c71 is further amended by adding at the end the following3 7d7 ,continuing education on infection control and patient safety 7#a7 ,in general ,the ,secretary shall establish a program to provide incentives 7in the form of grants or other assistance7 to ,state medical boards that require health care professionals 7as defined by the medical board7 to complete accredited coursework or training in infection control1 antibiotic stewardship1 or other patient safety topics as a condition of receiving a renewed license to practice in the ,state4 7#b7 ,exemption ,a ,state medical board that receives assistance under paragraph 7#a7 may provide an exemption from the coursework or training requirement under such paragraph for those health care professionals who have specialized training in infection control 7such as an infectious disease specialist or certified infection control practitioner71 who are not actively practicing in the ,state1 or who do not provide direct patient care4 7#c7 ,authorization of appropriations ,there is authorized to be appropriated1 such sums as may be necessary to carry out this subsection4 4 7b7 ,engaging hospital leadership in patient safety in ,medicare and ,medicaid 7#a7 ,medicare ,section #ahff7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;cc7a77#a771 as amended by section #d7;a77#a71 is amended-- 7,a7 in subparagraph 7,y71 by striking and at the end2 7,b7 in subparagraph 7,z71 by striking the period and inserting 1 and2 and 7,c7 by adding at the end the following new subparagraph3 7,,aa7 in the case of hospitals1 including critical access hospitals1 to require that new members of the board of such hospital1 not later than #f months after joining the board1 receive training 7in accordance with criteria established by the ,secretary7 on patient safety topics that are relevant to a hospital 7or critical access hospital1 as the case may be7 setting1 such as infection prevention1 care transitions1 patient safety and quality of care measurement1 and staff communication4 4 7#b7 ,medicaid ,section #aijb7;a77#hb7 of the ,social ,security ,act1 as added by section 7#e77;a77#b77;,c71 is amended by striking subparagraph 7,z7 and inserting subparagraphs 7,z7 and 7,,aa7 before the period4 7#c7 ,criteria ,not later than #f months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services shall propose and finalize criteria1 through notice and comment rulemaking1 specifying the number of hours and type of training that shall satisfy the training requirements imposed by the amendments made by paragraphs 7#a7 and 7#b74 ,such criteria shall be published on the ,internet website of the ,centers for ,medicare ,medicaid ,services4 7#d7 ,effective date 7,a7 ,medicare ,in the case of the requirement imposed by the amendments made by paragraph 7#a71 such requirement shall apply to agreements entered into or renewed on or after the date that is #cj days after the date of the publication of the criteria described in paragraph 7#c74 7,b7 ,medicaid 7i7 ,in general ,except as provided in clause 7ii71 the requirement imposed by the amendment made by paragraph 7#b7 shall take effect on the date that is #cj days after the date of the publication of the criteria described in paragraph 7#c74 7ii7 ,delay permitted if state legislation required ,in the case of a ,state plan for medical assistance under title ,,xix of the ,social ,security ,act which the ,secretary of ,health and ,human ,services determines requires ,state legislation 7other than legislation appropriating funds7 in order for the plan to meet the additional requirement imposed by paragraph 7#b71 the ,state plan shall not be regarded as failing to comply with the requirements of such title solely on the basis of its failure to meet this additional requirement before the first day of the first calendar quarter beginning after the close of the first regular session of the ,state legislature that begins after the date described in clause 7i74 ,for purposes of the previous sentence1 in the case of a ,state that has a #b-year legislative session1 each year of such session shall be deemed to be a separate regular session of the ,state legislature4 7c7 ,improvements to the ,patient ,safety and ,quality ,improvement ,act of #bjje ,section #ibc of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b-#bc7 is amended by adding at the end the following3 7d7 ,authority for direct reporting by patients 7#a7 ,in general ,a patient safety organization may collect information reported directly by patients on patient safety incidents and unsafe conditions4 ,such information shall not be deemed to be identifiable patient safety work product4 7#b7 ,requirements ,in collecting patient safety information 7including information submitted by patients under this subsection71 a patient safety organization shall-- 7,a7 ensure that all such information 7including any other patient safety work product received by the organization7 is submitted to the network of patient safety databases2 and 7,b7 ensure that such information is de-identified prior to submitting the information to the network of patient safety databases4 7#c7 ,development of best practices ,the ,director of the ,agency shall conduct research on best practices for enabling patient safety organizations to engage patients in reporting on patient safety incidents and for the collection by such organizations of such patient-reported information1 including a standardized format for the submission of such data by patients4 ,the ,director shall disseminate such best practices for use by patient safety organizations4 7#d7 ,accessibility ,the ,director of the ,agency shall establish a single access point on the ,internet website of the ,agency that may be accessed by the public to obtain patient safety data from the data that has been aggregated by the network of patient safety databases4 7#e7 ,authorization of appropriations ,there is authorized to be appropriated1 such sums as may be necessary to carry out this subsection4 4