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Updated March 2, 2006
Roger D. Klein, MD
Sheldon Campbell, MD, PhD
Peter J. Howanitz, MD
The following frequently asked questions are presented as a supplemental document
to the CAP Point-of-Care Testing Checklist. They are intended to serve as an
interpretive reference for laboratories, inspectors, representatives of government
and industry, and others who seek clarification of issues raised within the
current Point-of-Care Testing Checklist (March 2004).
The CAP is an accreditation organization that has been granted deeming authority
by the Centers for Medicare and Medicaid Services (CMS) pursuant to the Clinical
Laboratory Improvement Amendments of 1988 (CLIA 88). By virtue of this appointment,
the CAP is legally obligated during its inspections to adhere to the statutorily
mandated guidelines set forth in 42 U.S.C. §§ 263a – a7 (2001),
and to the regulations enumerated in 42 C.F.R. § 493.1 – 493.2001
(2003) by the CMS as provided for by Congress in the CLIA. Thus, the standards
enforced by the CAP through its Laboratory Accreditation Program must at a minimum
enforce those regulations as promulgated by the CMS. However, please note that
as the world’s leading organization for the promotion of high quality
laboratory testing, the CAP’s requirements in some instances go beyond
those set forth in CLIA and its accompanying regulations. In so doing, our goal
is to educate, to instruct, and to otherwise ensure that we provide our patients
with the best possible laboratory testing. These frequently asked questions
are in keeping with that spirit.
Note: The Point Of Care FAQ's are in the process of being updated andwill return shortly. Thank you for your patience.
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