College of American Pathologists

  Frequently Asked Questions Checklist


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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