3 in 1000 results would have been excluded by the CLIA 88
recommended imprecision (3) [[+ or -] 6 mg/dL ([+ or -] 0.
The addition of these FDA controls go above and beyond what's required of most clinical laboratories that are certified by the Federal Government under CLIA 88
(Clinical Labs Improvement Act, 1988).
Enforcement of both the Food Drug and Cosmetics Act and the Public Health Service Act [which created the CLIA 88
(CLIA amendments of 1988) framework] falls to the Department of Health and Human Services.
The system is classified as waived or moderately complex under CLIA 88
We offer the physician and other health care professionals the only multi-analyte chemistry system waived under CLIA 88
that meets National Cholesterol Education Program guidelines for total and HDL cholesterol screening.
As a full-service proficiency-testing provider approved by HCFA (Health Care Financing Administration; now, the Centers for Medicare and Medicaid Services or CMS), the Wisconsin State Laboratory of Hygiene proficiency testing (WSLH PT) program also made changes to bring it into compliance with CLIA 88
The enactment of CLIA 88
unraveled the comfortable existence of a few large PT providers who primarily served hospital laboratories.
To our knowledge, the Cholestech L-D-X System is still the only multi-analyte chemistry system waived under CLIA 88
With the crucial elements of CLIA 88
unveiled, members of the lab industry are laboring to define the impact of the Clinical Laboratory Improvement Amendments of 1988.
The Health Care Financing Administration HCFA) estimates the price of CLIA 88
To the contrary, site neutrality is a major element of the legislative intent of CLIA 88
and a requirement which Congress felt was demanded by the citizens.
CLIA 188 test categories Laboratories can determine which level of regulatory scrutiny they will experience from CLIA 88
by checking the following list of test categories.