Adopting Standards for Laboratory Requirements

The Department of Veterans Affairs (VA) adopts as final, with changes, a proposed rule amending 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 the assessment of the health 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 rule formalizes this practice. In response to public comments this final rulemaking amends proposed language to more accurately reflect VA's utilization of CMS-deemed accreditation organizations in the process of inspection, oversight, and operational approval of VA clinical laboratories.