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VA RIN: 2900-AP64 Publication ID: Spring 2019 
Title: Adopting Standards for Laboratory Requirements 
Abstract:

The Department of Veterans Affairs (VA) amends its medical regulations to establish standards for VA clinical laboratories. The Department of Health and Human Services (HHS) has established standards for the staffing, management, procedures, and oversight of clinical laboratories that perform testing used for the diagnosis, prevention, or treatment of any disease or impairment of, or health assessment of, human beings. VA is required, in consultation with HHS, to establish standards equal to those applicable to other clinical laboratories. As a matter of policy and practice VA has applied HHS standards to its VA laboratory operations, and this final rule would formalize this practice. The final rule would establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid and tissue, for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health. Specifically, it would address how VA applies regulations as the controlling standards for VA medical facility laboratories.

 

 
Agency: Department of Veterans Affairs(VA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 38 CFR 17.3500   
Legal Authority: 38 U.S.C. 501   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  10/17/2018  83 FR 52345   
NPRM Comment Period End  12/17/2018 
Final Action  12/00/2019 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Information URL: www.regulations.gov  
RIN Data Printed in the FR: No 
Agency Contact:
Quynh Vantu
Health Science Specialist
Department of Veterans Affairs
810 Vermont Avenue NW.,
Washington, DC 20420
Phone:202 632-8418