scope:

PURPOSE. This instruction:

a. Reissues DoD Instruction (DoDI) 6440.2 (Reference (a)), in accordance with the authority in DoD Directive 5124.02 (Reference (b)) and pursuant to the Memorandum of Understanding between the Department of Defense and the Department of Health and Human Services (HHS) (Reference (c)), Public Law 100-578 (Reference (d)), and part 493 of Title 42, Code of Federal Regulations (Reference (e)), to establish policy, assign responsibilities, and prescribe standards and procedures to implement and administer the CLIP within the DoD.

b. Establishes the Center for Clinical Laboratory Medicine (CCLM), formerly known as the Clinical Laboratory Improvement Program Office, under the Defense Health Agency (DHA). CCLM has the primary responsibility to develop Clinical Laboratory Improvement Amendments (CLIA) comparable regulations and administer the CLIP in accordance with Reference (c).

APPLICABILITY. This instruction applies to the OSD, the Military Departments, the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD Field Activities, and all other organizational entities within the DoD (referred to collectively in this instruction as the "DoD Components").