Knowing that all Quest Diagnostics' testing locations are appropriately licensed/certified by CLIA 88
and adhere to state laboratory licensure programs gave me more confidence--as we all know, accuracy is dependent on the quality of the laboratory's testing procedures.
With the RiLiBAEK IQC target imprecision for glucose (CV, [+ or -] 11%), 1 in 1000 of our differences would have been excluded as outliers, and 0.3 in 1000 results would have been excluded by the CLIA 88
recommended imprecision (3) [[+ or -] 6 mg/dL ([+ or -] 0.83 mmol/L) or [+ or -] 10% <76 mg/dL (<4.2 mmol/ L), whichever is reached first; and [+ or -] 20% >76 mg/dL (>4.2 mmol/L)].
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).
The minimum guidelines according to CLIA 88
(2003) require laboratories to perform external quality control at least one time per eight-hour shift.
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.
Waived testing--simple tests performed at the point of care that are "waived" from most federal and state oversight under the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88
)--is on the rise, and with it, the potential for quality problems.
The Clinical Laboratory Improvement Amendments of 1988 (CLIA 88
) (1) have caused great changes not only in US laboratories but in clinical laboratories throughout the world.
The system is classified as waived or moderately complex under CLIA 88
With the implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88
), proficiency testing (PT) programs assumed an even greater regulatory role than held previously.
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
at 1.2 billion to $2.1 billion, which works out to a cost increase of 25 cents per lab test.