Clinical laboratory improvement program manual

The Clinical Laboratory Improvement Amendments of (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. The Clinical Quality Management Plan (CQMP) establishes the quality management guidelines for tasks related to the NIDCR Protocol. The purpose of the CQMP is to identify and document the ongoing processes and activities that will be used to monitor and facilitate quality protocol execution following study initiation. Approved State laboratory program means a licensure or other regulatory program for laboratories in a State, CLIA means the Clinical Laboratory Improvement Amendments of Reagents and materials preparation may include manual steps such as gravimetric or volumetric measurements. (4).

As part of CFSAN’s QMS, the Laboratory Quality Manual (LQM) provides an operational framework in which the Center’s laboratory quality assurance program can operate. The LQM defines quality. The Division of Clinical Laboratory Improvement Quality, within the Quality, Safety Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program. The objective of the CLIA program is to ensure quality laboratory testing. The Clinical Laboratory Improvement Amendments (CLIA) comparable regulations in this manual incorporate, to the maximum extent possible, the regulations issued by HHS in accordance with Reference (e), modified only to meet unique aspects of DoD missions, training.

The Clinical Laboratory Improvement Amendments (CLIA) were passed by Congress be completed and signed and appropriate documentation attached for initial. A memorandum of agreement between the Department of Health and Human Services and the Department of Defense (DOD) established the DOD Clinical Laboratory. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory and must register with the CLIA program. Laboratories are not.