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È Professional medical society that provides excellence in
education, certification, and advocacy on behalf of patients,
pathologists and laboratory professionals
È 130,000 member pathologists and laboratory professionals

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È mvaluating and accrediting hospital laboratory services since
1979 and freestanding laboratories since 1995
È Accredits almost 2,000 organizations providing laboratory
services
È This represents almost 3,000 CLIA-certified laboratories
including freestanding laboratories, such as reference labs, in-
vitro fertilization labs, and those connected with other
healthcare organizations such as ambulatory surgical centers
and long term care facilities
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È Can predict risk for developing
disease
È More accurately diagnose disease
È mnable customized treatment and
disease management for common
chronic conditions (cancer, heart
disease, diabetes) as well as rare
genetic disorders
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È reliable
È Safe
È Provide valid and useful information for
clinical decision-making
È Performed by competent laboratories
È Used by clinicians adequately trained to
interpret them
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È risk-based regulation through enhanced
coordination between FDA & CLIA-
regulating agencies
È LDTs of moderate complexity continue to
be regulated by CLIA
È mnhanced accreditation process through a
combination of governmental and non-
governmental organizations
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È CLIA process should ensure data collection
that substantiates clinical validity claims
È PT for non-waived genetic laboratory tests,
if available
È HHS funding to evaluated alternative
performance assessment methods
È Protocol should maintain advantages of
multi-site PT while addressing the risks of
inter-laboratory variation
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È requiring clinical utility may impede or
prevent patient access to assays
È Lengthy approval procedures could delay
implementation of new tests, stifle
innovation, and increase development
costs
È Low volume LDTs (rare genetic tests) have
limited population for clinical trial testing
È mxpense may cause smaller labs to
abandon this area of testing






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Thank you.