,i #aafth ,,congress #b;d ,session ,h4 ,r4 #ijcg ,,in ,,the ,,house ,,of ,,representatives ,december #bj1 #bjbj,ms4 ,gabbard introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,public ,health ,service ,act to ensure transparency within the health care system through the establishment of a ,national ,healthcare ,acquired ,infection and ,medical ,error ,reporting ,program4 #a4 ,short title ,this ,act may be cited as the ,national ,healthcare ,acquired ,infection and ,medical ,error ,transparency ,act4 #b4 ,findings 7#a7 ,the ,centers for ,disease ,control and ,prevention reported that each day one in thirty-one hospital patients has at least one healthcare-associated infection2 7#b7 #cb percent of all healthcare-acquired infections are urinary tract2 7#c7 #bb percent of all infections are surgical site infections2 7#d7 #ae percent are pneumonia 7lung infections72 7#e7 #ad percent are bloodstream infections4 7#f7 ,patients who acquire infections from surgery spend on average an additional #f4e days hospitalized2 7#g7 are five times more likely to be readmitted after discharge2 7#h7 and are twice as likely to die4 7#i7 ,as recent as #bjaf1 ,johns ,hopkins ,university patient safety experts calculated that medical error is responsible for at least #bej1jjj deaths per year 7the third leading cause of death in the ,u4,s474 #c4 ,establishment of ,office of ,patient ,safety and ,health ,care ,quality ,title ,,ix of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii et seq47 is amended-- 7#a7 by redesignating part ,e as part ,f2 7#b7 in part ,f1 as redesignated-- 7,a7 by redesignating sections #ida through #idh as sections #iea through #ieh1 respectively2 and 7,b7 in section #ieh7a71 as redesignated1 by striking #8#8#ida'' and inserting #8#8#iea''2 and 7#c7 by inserting after part ,d the following3 ,e ,national ,healthcare ,acquired ,infection and ,medical ,error ,reporting ,program #ida4 ,definitions ,in this part3 7#a7 ,anti-retaliation ,the term anti-retaliation any patient or legal representative of a patient who engages in ,protected ,activity will be shielded from retaliation4 7#b7 ,database ,the term ,database means the ,national ,patient ,safety ,database established under section #idd4 7#c7 ,health care provider ,the term health care provider means a person or entity licensed or otherwise authorized under ,state law to provide health care services1 including-- 7,a7 a hospital1 health plan1 community clinic1 nursing facility1 comprehensive rehabilitation facility1 home health agency1 hospice program1 renal dialysis facility1 ambulatory surgical center1 pharmacy1 doctor's or health care practitioner's office1 long-term care facility1 behavior health residential treatment facility1 clinical laboratory1 or health center2 7,b7 a doctor1 nurse1 physician assistant1 nurse practitioner1 clinical nurse specialist1 certified nurse anesthetist1 certified nurse midwife1 psychologist1 certified social worker1 registered dietitian or nutrition professional1 physical or occupational therapists1 pharmacist1 or other individual healthcare practitioner2 and 7,c7 any other health care professional specified in regulations promulgated by the ,secretary4 7#d7 ,healthcare ,acquired ,infection ,the term ,healthcare ,acquired ,infection7s7 7,,hai7 means an infection that is contracted while in a healthcare facility1 such as an acute care hospital1 skilled nursing care facility1 or doctor's office or clinic4 7#f7 ,medical error ,the term medical error means an unexpected occurrence involving death or serious physical or psychological injury1 or the risk of such injury1 including any process variation of which recurrence may carry significant chance of a serious adverse outcome4 7#g7 ,office ,the term ,office means the ,office of ,patient ,safety and ,health ,care ,quality established under section #idc1 which shall be a certified patient safety organization as defined under part ,c4 7#h7 ,outcomes ,the term outcomes means any result of healthcare acquired infection and_/or medical error on affected patients4 7#i7 ,patient safety data ,the term patient safety data means information requested by the ,director of the ,office to be submitted by the patient safety officer of a ,program participant as described in section #ide7;e74 7#f7 ,patient safety event ,the term patient safety event means an occurrence1 incident1 or process that either contributes to1 or has the potential to contribute to1 a patient injury or degrades the ability of health care providers to provide the appropriate standard of care4 7#g7 ,patient safety officer ,the term patient safety officer means the individual designated by a ,program participant as being responsible for ensuring that the conditions for participation in the ,program are met4 7#h7 ,patient safety organization ,the term patient safety organization has the meaning given such term in section #iba4 7#i7 ,patient safety work product ,the term patient safety work product has the meaning given such term in section #iba4 7#aj7 ,program ,the term ,program means the ,national ,healthcare ,acquired ,infections and ,medical ,error ,reporting ,program established under section #ide4 7#aa7 ,program participant ,the term program participant means any healthcare provider who reports healthcare acquired infections and_/or medical errors to the ,national ,healthcare ,acquired ,infections and ,medical ,error ,reporting ,program4 7#ab7 ,root cause analysis ,the term root cause analysis means an examination or investigation of an occurrence1 event1 or incident to determine if a preventable medical error took place or the standard of care was not followed and to identify the causal factors that led to such occurrence1 event1 or incident4 7#ad7 ,whistleblower ,the term whistleblower means any individual or legal representative of an individual1 who provides original information relating to a ,healthcare ,acquired ,infection or ,medical ,error outcome4 #idb4 ,purpose and goals ,it is the purpose of this legislation to promote a culture of safety and trust within hospitals1 health systems1 clinics1 and other sites of health care1 through the establishment of a ,national ,healthcare ,acquired ,infection and ,medical ,error ,reporting ,program4 ,it shall be a goal of the ,program to-- 7#a7 establish standardized procedures for ,states to provide reports detailing healthcare acquired infection and medical error disclosure and reporting2 7#b7 require all ,state departments of health to use the data provided by hospitals for error reporting to analyze trends and identify best practices2 7#c7 reduce rates of preventable medical errors2 and 7#d7 ensure patients have access to information for medical injury or illness due to medical error1 negligence1 or malpractice4 #idc4 ,office of ,patient ,safety and ,health ,care ,quality 7a7 ,in ,general ,the ,secretary shall establish within the ,office of the ,secretary1 an ,office of ,patient ,safety and ,health ,care ,quality to collaborate with the ,director of the ,agency for ,health ,care ,research and ,quality to improve patient safety and reduce medical error across the health care system4 ,the ,office shall be headed by a ,director to be appointed by the ,secretary4 7b7 ,activities ,the activities of the ,office shall be deemed patient safety activities1 as defined in section #iba4 7c7 ,duties ,the ,director of the ,office shall-- 7#a7 establish and administer the ,program2 7#b7 determine who is eligible for participation in the ,program in accordance with section #ide2 7#c7 contract with an independent entity for the purpose of evaluating the ,program at least once every two years1 with the results of such evaluations being disseminated to ,program participants1 ,congress1 and the public2 7#d7 establish and maintain1 in consultation with patient safety organizations1 health care quality organizations1 health care providers1 and the health information technology industry1 a ,national ,patient ,safety ,database as provided for in section #idd to receive nonidentifiable patient safety work product as described in the reporting requirements for ,program participants under section #ide7;c77#aj72 7#e7 determine and adopt a standardized patient safety taxonomy1 necessary elements1 common and consistent definitions1 and standardized formats for the electronic reporting of patient safety data to the ,database as described in section #idd7;e72 7#f7 survey ,federal1 ,state1 and local requirements for the reporting of patient safety data and work to streamline and reduce duplication of such requirements2 7#g7 grant patient safety organizations1 researchers1 and other qualified individuals and institutions access to the ,database as determined appropriate through the evaluation of completed applications submitted to the ,office for such purpose2 7#h7 analyze1 directly or through a contract with a patient safety organization1 all data entered into the ,database and provide ,program participants1 ,congress1 and the public with healthcare acquired infection and medical error trend reports and other analyses as determined appropriate by the ,director on a quarterly basis2 7#i7 develop1 directly or through a contract with a patient safety organization1 safety and training recommendations for health care providers that focus on the reduction of medical errors1 improved patient safety1 and increased quality of care on at least a yearly basis2 7#aj7 maintain a publicly accessible internet website to provide patients and health care providers with information concerning the ,program and the ,database2 and 7#aa7 perform any other duties for the administration of the ,program as determined necessary by the ,secretary4 7d7 ,authorization of ,appropriations ,there are authorized to be appropriated such sums as may be necessary for each fiscal year to carry out the activities of the ,office4 #idd4 ,national ,patient ,safety ,database 7a7 ,in ,general ,the ,director of the ,office shall1 in accordance with section #idc7;c77#f71 establish a ,national ,patient ,safety ,database that shall-- 7#a7 adopt standardized patient safety taxonomy in consultation with the ,joint ,commission on ,accreditation of the ,healthcare ,organizations and other entities with relevant expertise2 7#b7 include necessary elements1 common and consistent definitions1 and a standardized electronic interface for the entry and processing of the data by ,program participants1 as developed by the ,director in consultation with patient safety organizations1 health care providers1 and the health information technology industry2 7#c7 allow for the comprehensive collection and analysis of the patient safety data required to be submitted by all ,program participants under section #ide2 and 7#d7 include patient safety data required to be submitted by ,program participants under section #ide as nonidentifiable patient safety work product and privileged and confidential in accordance with section #ibb4 7b7 ,limitation ,information submitted to the ,database shall be confidential and protected from disclosure in accordance with the regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note74 7c7 ,access ,access to the patient safety data contained within the ,database shall only be provided through application to and approval by the ,director4 #ide4 ,national ,healthcare ,acquired ,infection and ,medical ,error ,reporting ,program 7a7 ,establishment ,the ,secretary1 acting through the ,director of the ,office1 shall establish a ,national ,healthcare ,acquired ,infection and ,medical ,error ,reporting ,program to provide for the confidential disclosure of medical errors and patient safety events in order to improve patient safety and health care quality1 reduce preventable medical errors1 ensure patient access to data and reports for medical injury due to medical error1 negligence1 or malpractice4 7b7 ,eligible ,participants ,to be eligible to participate in the ,program an entity shall-- 7#a7 7,a7 be a healthcare provider2 or 7,b7 be any other entity determined to be eligible by the ,director2 7#b7 designate a patient safety officer to ensure that the conditions of participation described in subsection 7c7 are met2 7#c7 submit a completed application to the ,office at such time1 in such manner1 and containing such information as the ,director may require2 and 7#d7 agree to comply with the conditions of participation under subsection 7c74 7c7 ,conditions of ,participation ,a ,program participant shall1 directly or indirectly-- 7#a7 submit a comprehensive plan1 as part of the application for participation in the ,program1 to reduce the incidence of medical errors and improve patient safety in the case of a ,program participant that is a health care provider1 activities that result in the reduction of medical errors or that otherwise improve patient safety2 7#b7 require health care providers included in the ,program by the ,program participant and as outlined in the ,program participant application1 to submit to the patient safety officer a report of any incident or occurrence involving a patient that is thought to either be a medical error or patient safety event2 7#c7 ensure that the reports filed under paragraph 7#b7 are submitted to the ,database in a standardized format as designated by the ,director2 7#d7 where appropriate1 ensure that a root cause analysis of any report submitted to the patient safety officer under paragraph 7#b7 is performed within #ij days of the filing of a report under such paragraph2 7#e7 ensure that if a patient was harmed or injured as the result of a healthcare acquired infection or medical error1 or as a result of the relevant standard of care not being followed1 an account of the incident or occurrence1 as described in paragraph 7#b7 shall be disclosed to the patient not later than #e business days after the completion of root cause analysis2 7#f7 disclose information contained in any report submitted to the patient safety officer under paragraph 7#b7 upon the request of the patient with respect to whom the report has been filed2 7#g7 offer1 at the time of disclosure of an incident or occurrence in which it was determined that a patient was harmed or injured as a result of medical error or as a result of the relevant standard of care not being followed1 to share1 where practicable1 any efforts the health care provider will undertake to prevent reoccurrence2 and 7#h7 prepare and submit entries to the ,database as required by the ,director of the ,office and in accordance with subsection 7d74 7d7 ,submission of ,patient ,safety ,data 7#a7 ,in ,general ,all entries into the ,database shall-- 7,a7 contain only non-identifiable patient safety work product2 7,b7 be in a standardized electronic format to be determined by the ,director2 and 7,c7 if related to a single occurrence or incident1 be given a common identifier to link entries of related data4 7#b7 ,reporting requirements ,the patient safety officer of a ,program participant shall be required to prepare and enter into the ,database-- 7,a7 reports1 containing only nonidentifiable patient safety work product1 filed by a health care provider under subsection 7c77#d7 and a summary of the findings of the root cause analysis with respect to such report within #e business days of the completion of the root cause analysis2 7,b7 any disciplinary actions taken against a health care provider as a result of involvement in any incident or occurrence involving a patient that is thought to be a medical error or patient safety event1 or legal action for which a report under subsection 7c77#d7 was filed2 or 7,c7 other data as determined appropriate by the ,director4 7#c7 ,privilege and confidentiality ,the provisions of section #ibb shall apply to patient safety data submitted under this subsection4 #idf4 ,the ,national ,healthcare ,acquired ,infection and ,medical ,error ,reporting ,accountability ,study 7a7 ,in ,general ,the ,director of the ,office shall conduct1 directly or through a contract with patient safety organizations or qualified individuals or institutions1 an analysis of the patient safety data in the ,database and other available data to determine performance and systems standards1 tools1 and best practices 7including peer review7 for doctors and other health care providers necessary to prevent medical errors1 improve patient safety1 and increase accountability within the health care system4 ,such analysis shall also consider the value of increasing the transparency of the patient safety data to include the identity of health care providers and provide recommendations for improvements to the peer review process4 7b7 ,report and ,recommendations ,not later than #b years after the date of enactment of this section1 the ,director of the ,office shall submit to ,congress and make available to ,states1 ,state medical boards1 and the public a report that describes the results of the study carried out under subsection 7a7 and contains recommendations for ,congress based on the findings of the report4 4