1) While LDTs are considered to be a type of IVD, historically the FDA has opted to not impose the same regulatory oversight to LDTs as it does commercially available IVDs, leaving most LDTs to the regulatory arm of the CLIA '88
amendments, administered by the CMS.
Many years ago when CLIA '88
was introduced, I was given a passport and was transported to this new land.
requires directors to actively monitor PT results.
was implemented in 1992 to ensure that all laboratories meet the same minimal standards, based on the complexity of testing performed rather than by location.
Clinical laboratories, however, must comply with the performance criteria for blood lead set under CLIA '88
Respondents were asked a series of questions pertaining to the types of laboratory tests performed in their offices, and whether CLIA '88
had any influence on the decision to change testing practices.
CDC, the Association of State and Territorial Public Health Laboratory Directors, the National Laboratory Training Network, and the Florida Department of Health and Rehabilitative Services are cosponsoring a training course titled "Directing the Laboratory Performing Moderate Complexity Tests: Quality Laboratory Management for Meeting CLIA '88
Requirements" on June 9, 16, and 23.
PerkinElmer Genetics has established and verified its tests' accuracy and precision as required under CLIA '88
It was the first system of its kind to incorporate CLIA '88
First, CLIA '88
requires that at least 10% of Papanicolaou (Pap) tests interpreted as "negative for intraepithelial lesion or malignancy" (NILM) by each cytotechnologist be rescreened by a qualified supervisory cytotechnologist or pathologist before reporting.
The acceptable range for results reported to BPb PT schemes accredited under CLIA '88
is [+ or -] 0.
Of the 122 returns, 64 (52%) were within 5% of the expected value, 98 (80%) were within 10%, and 114 (93%) were within 15% (the accuracy limit defined by the proposed CLIA '88
regulations for serum cholesterol determinations).