2001D-0044 Clinical Laboratory Improvement Amendments of 1988
FDA Comment Number : EC2
Submitter : Mr. Edward Adams Date & Time: 10/05/2005 04:10:15
Organization : DPHHS, QA Division, CLIA
Category : State Government
Issue Areas/Comments
GENERAL
GENERAL
Instructions are clear and direct. QC must cover all aspects and made clear to operator. Points I found particularly valuable to be included are: - scientifically based studies, - emphasis on QC, patient specimens, requires no technical or specialized training, no operator calibration, quick reference sheet, lock out function, internal controls AND external controls, QC limits, QC checks all aspects of the procedure, action to take if controls are out, inclusion of examples, near cut offs, and the med-watch program.