For Blood / Biologics

Blood Center Accreditation by CAP Can Boost FDA Compliance

CAP Accreditation Beneficial for FDA-Regulated Blood Centers and Blood Establishments

FDA-regulated blood centers, clinical laboratories, and related establishments are under tremendous pressure to maintain the highest standards for blood and tissue quality.

For many of these organizations, an accreditation by the College of American Pathologists (CAP) will help them meet, if not exceed, FDA requirements. The CAP Laboratory Accreditation Program is generally recognized as equal to, or more stringent than, the U.S. government's inspection program.

The CAP Accreditation Program helps improve the quality of clinical laboratory services through voluntary participation, professional peer review, education, and compliance with established performance standards.

Laboratories in different settings ? from hospitals to contract research organizations ?discover that CAP accreditation standards can help them set requirements on such things as leadership, physical facilities, safety, quality control, and performance improvement. The CAP inspection program consists of on-site inspection by an external team and interim self-inspection.

A blood center's accreditation can increase the organization's motivation to strengthen processes meant to reduce the risks of blood contamination and infectious disease transmission. It can also serve as further proof of the blood center's high standards.

In both the FDA and CAP environments, there are areas considered critical to quality improvement. Document control is one of them. The process for controlling the creation, review, approval, distribution, and revision of documents is as important in CAP accreditation as it is in FDA compliance.

Learn more about document control, CAP accreditation standards, and how a blood center's accreditation can be a step in the right direction toward FDA compliance.

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CAP Accreditation and Document Control

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FDA Links

  • Federal Register announcement: CAP as an accrediting organization for CLIA
    Link


  • CBER Compliance Program Manual
    Link


  • Compliance and Surveillance
    Link

CAP Links

  • CAP Web site
    Link


  • Accreditation and Laboratory Improvement
    Link


  • FDA Tightens Rules
    Link

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