,,ii #aafth ,,congress #b;d ,session ,s4 #ceab ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #ag1 #bjbj,mr4 ,paul introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to clarify the authority for regulating laboratory-developed testing procedures4 #a4 ,short title ,this ,act may be cited as the ,verified ,innovative ,testing in ,american ,laboratories ,act of #bjbj or the ,,vital ,act of #bjbj4 #b4 ,laboratory-developed testing procedures 7a7 ,findings ,congress finds the following3 7#a7 ,laboratory testing services are an integral part of medical decision making1 health management1 and public health surveillance4 7#b7 ,provision of laboratory services is a professional health care activity1 which is regulated under the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bja et seq474 7#c7 ,as witnessed with the #bjbj ,,covid-#ai pandemic1 undue regulation of laboratory-developed testing procedures may hamper the medical management and public health response to infectious disease outbreaks and pandemics1 leading to delays in access to testing and the ability to meet needed capacity to stem community spread4 7b7 ,sense of ,congress ,it is the sense of ,congress that-- 7#a7 the ,federal ,government should work to-- 7,a7 ensure that patients receive the most appropriate tests and procedures for medical evaluations or treatment of clinical conditions2 7,b7 ensure that laboratory-developed testing procedures are accurate1 precise1 clinically-relevant1 and monitored for continued quality performance2 7,c7 enable laboratory professionals to provide professional services without undue restrictions2 7,d7 ensure that regulatory oversight of laboratory tests does not limit patient access1 impede innovation1 constrain flexibility or adaptability1 or limit a test's sustainability as a result of being unduly burdensome or beyond the fiscal capacity of the laboratory to reasonably validate and perform1 or the health care system to financially support2 7,e7 preserve the ability of the laboratory community to provide surge capacity in public health emergencies1 including biological1 chemical1 radiological1 and nuclear threats1 infectious disease outbreaks1 or other emergent situations2 and 7,f7 safeguard1 strengthen1 and expand the existing ,laboratory ,response ,network1 including public health laboratories1 sentinel laboratories1 national laboratories1 commercial reference laboratories1 academic medical center laboratories1 and hospital-based laboratories2 and 7#b7 laboratories using laboratory-developed testing procedures should adhere to personnel requirements required under section #cec of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfc;a71 including such requirements relating to qualified professionals who direct and supervise laboratories and consult on diagnosis1 treatment1 and management of patient care1 and render opinions to clients concerning diagnosis1 treatment1 and management of patient care required under such section #cec4 7c7 ,authority over laboratory-,developed testing procedures ,all aspects of a laboratory-developed testing procedures shall be regulated by the ,secretary of ,health and ,human ,services under section #cec of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfc;a71 and no aspects of laboratory-developed testing procedures shall be regulated under the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cja et seq471 including during a public health emergency declared under section #cai of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d74 7d7 ,definition ,in this section1 the term laboratory-developed testing procedure means a professional medical service that utilizes a laboratory examination in the context of clinical care or public health services and that meets the standards for establishment of performance specifications established by regulation under section #cec7;f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfc;a7f77 applicable to-- 7#a7 laboratory modifications of test systems approved1 cleared1 or authorized by the ,food and ,drug ,administration under section #eaj7k71 #eac1 #eae1 or #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k71 #cfj;c1 #cfj;e1 #cfj;bbb-#c72 7#b7 methods developed or performed1 and results produced and interpreted1 within a laboratory or laboratories under common ownership or within the same organization1 certified as required under section #cec7;c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfc;a7c772 7#c7 standardized methods such as those that are available in textbooks and peer-reviewed publications2 or 7#d7 methods in which performance specifications are not provided by the manufacturer of test systems or components4 7e7 ,public meeting ,not later than #ij days after the date of enactment of this ,act1 the ,administrator of the ,centers for ,medicare ,medicaid ,services shall hold a public meeting to solicit recommendations on updating the regulations under section #cec of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfc;a74 7f7 ,report to ,congress ,not later than #ahj days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall report to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives1 the following3 7#a7 ,recommendations to update section #cec of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfc;a7 and the regulations promulgated under such section1 taking into consideration input and recommendations from the ,clinical ,laboratory ,improvement ,advisory ,committee1 to reflect the current state of the field of clinical laboratory testing4 7#b7 ,an assessment of the availability and utilization of laboratory-developed testing procedures during the #bjbj ,,covid-#ai pandemic response that includes-- 7,a7 validation criteria and process1 and average length of time from validation to achieving emergency use authorization under section #efd of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;bbb-#c7 before1 and after1 ,february #bi1 #bjbj2 7,b7 the number of patients and samples tested by laboratories using such testing procedures2 and 7,c7 recommendations to ensure that during future infectious disease outbreaks1 the public health system and clinical laboratories do not encounter delays to testing4