DoDM 6440.02 临床实验室改进计划（CLIP）程序.pdf

Department of Defense MANUAL NUMBER 6440.02 May 29,2014 Incorporating Change 1,Effective August 5,2020 USD(P&R)SUBJECT:Clinical Laboratory Improvement Program(CLIP)Procedures References:See Enclosure 1 1.PURPOSE.In accordance with the authority in DoD Directive 5136.01(Reference(a)andthe policy in DoD Instruction(DoDI)6440.02(Reference(b),this manual implements policy,assigns responsibilities,and provides for standards and procedures for managing the CLIP.Thismanual states the minimal conditions that all laboratories must meet to be certified to performtesting on human specimens under the CLIP.2.APPLICABILITY.This manual applies to:a.The OSD,the Military Departments,the Office of the Chairman of the Joint Chiefs ofStaff and the Joint Staff,the Combatant Commands,the Office of the Inspector General of the DoD,the Defense Agencies,the DoD Field Activities,and all other organizational entities within the DoD(referred to in this manual as the“DoD Components”).b.All medical laboratories as defined in the Glossary.The Center for Clinical LaboratoryMedicine(CCLM)issues certificates of accreditation within the DoD in lieu of Department of Health and Human Services(HHS).This manual states t