2001D-0044 Clinical Laboratory Improvement Amendments of 1988
FDA Comment Number : EC3
Submitter : Mr. Gary Gennetta Date & Time: 10/17/2005 11:10:22
Organization : CDPHE
Category : State Government
Issue Areas/Comments
1. The word 'recommend' has caused great confusion and difficulty in interpreting and enforcing the regulations for quality control, both for laboratories and CLIA surveyors. Refer to Page 30 under QC: 'external controls are ALWAYS RECOMMENDED...and are CRITICAL if you are using them as a failure alert...' If external controls are critical in meeting the requirements can this word (recommend) either be defined in the definitions as being something the laboratory MUST do or can the recommendation be reworded to say MUST? 2. Another helpful piece of information would be for the manufacturer to clearly mark on the outside of the kit and in the package insert the complexity of the test (Waived or Non-Waived).