,i  #aafth ,,congress  #b;d ,session    
,h4 ,r4 #fhci  ,,in ,,the ,,house ,,of  
,,representatives  ,may #ab1 #bjbj,ms4  
,spanberger 7for herself and ,mr4       
,gonzalez of ,ohio7 introduced the      
following bill2 which was referred to   
the ,committee on ,energy and ,commerce 
,a ,,bill  ,to direct the ,comptroller  
,general of the ,united ,states to      
submit a report describing the response 
of certain entities to the ,,covid-#ai  
pandemic with respect to the            
development1 regulatory evaluation1 and 
deployment of diagnostic tests4  #a4    
,,gao report on diagnostic tests  7a7   
,,gao study ,not later than #ah months  
after the date of enactment of this     
,act1 the ,comptroller ,general of the  
,united ,states shall submit to the     
,committee on ,energy and ,commerce of  
the ,house of ,representatives and the  
,committee on ,health1 ,education1      
,labor and ,pensions of the ,senate a   
report describing the response of       
entities described in subsection 7b7 to 

the ,,covid-#ai pandemic with respect to
 the development1 regulatory evaluation1
 and deployment of diagnostic tests4    
7b7 ,entities described ,entities       
described in this subsection include--  
7#a7 laboratories1 including public     
health1 academic1 clinical1 and         
commercial laboratories2  7#b7          
diagnostic test manufacturers2  7#c7    
,state1 local1 ,tribal1 and territorial 
governments2 and  7#d7 the ,food and    
,drug ,administration1 the ,centers for 
,disease ,control and ,prevention1 the  
,centers for ,medicare  ,medicaid       
,services1 the ,national ,institutes of 
,health1 and other relevant ,federal    
agencies1 as appropriate4  7c7 ,contents
 ,the report under subsection 7a7 shall 
include-- 7#a7 a description of actions 
taken by entities described in          
subsection 7b7 to develop1 evaluate1 and
 deploy diagnostic tests2  7#b7 an      
assessment of the coordination of       
,federal agencies in the development1   
regulatory evaluation1 and deployment of

 diagnostic tests2  7#c7 an assessment  
of the standards used by the ,food and  
,drug ,administration to evaluate       
diagnostic tests2  7#d7 an assessment of
 the clarity of ,federal agency guidance
 related to testing1 including the      
ability for individuals without medical 
training to understand which diagnostic 
tests had been evaluated by the ,food   
and ,drug ,administration2  7#e7 a      
description of-- 7,a7 actions taken and 
clinical processes employed by ,states  
and territories that have authorized    
laboratories to develop and perform     
diagnostic tests not authorized1        
approved1 or cleared by the ,food and   
,drug ,administration1 including actions
 of such ,states and territories to     
evaluate the accuracy and sensitivity of
 such tests2 and  7,b7 the standards    
used by ,states and territories when    
deciding when to authorize laboratories 
to develop or perform diagnostic tests2 
7#f7 an assessment of the steps taken by
 laboratories and diagnostic test       

manufacturers to validate diagnostic    
tests1 as well as the evidence collected
 by such entities to support validation2
 and  7#g7 based on available reports1  
an assessment of the accuracy and       
sensitivity of a representative sample  
of available diagnostic tests4  7d7     
,definition ,in this section1 the term  
diagnostic test means an in vitro       
diagnostic product 7as defined in       
section #hji4c7;a7 of title #ba1 ,code  
of ,federal ,regulations7 for-- 7#a7 the
 detection of ,,sars-,co,v-#b2  7#b7 the
 diagnosis of the virus that causes     
,,covid-#ai2 or  7#c7 the detection of  
antibodies specific to ,,sars-,co,v-#b1 
such as a serological test4