CMS Requirements for Hospital Laboratory Services
by Chad Niemeyer, from the Community
Comprehensive summary of CMS Condition of Participation 482.27 for hospital laboratory services. Covers CLIA certification for all lab services, integration with QAPI, treatment of lab results as medical records, 24/7 emergency testing availability, written policies for tissue specimen collection and examination, and responsibilities for blood and blood component safety, lookback, quarantine, recordkeeping, and patient notification. Applicable to on-campus, off-campus, and contracted services; emphasizes medical staff roles and adherence to federal and state regulations.
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