CLIA and CAP Labeling

Tissue identification requirements for CLIA and CAP compliance

The industry's best practices for tissue identification are established by the College of American Pathologists (CAP) and the Clinical Laboratory Improvement Amendments (CLIA). Both the CAP and CLIA standards emphasize lab automation as a means of improving patient safety.

CAP Compliance:

The College of American Pathologists is the leading organization that fosters and advocates excellence in the practice of pathology and laboratory medicine. CAP guidelines for specimen management are aimed at tracking each time a specimen container, slide or block is labeled or numbered for tissue identification.

CLIA Compliance:

• The Clinical Laboratory Improvement Amendments of 1988 (CLIA) apply to all laboratories that examine human specimens for diagnosing, treating or preventing disease. 
• Laboratories performing high-complexity tests are required to meet all applicable standards of 42 CFR 493.
• Each test has different quality control measures capabilities, performance characteristics, procedures and technologies.
• Continually updated to incorporate the latest technologies and practices.

Components needed to execute a compliant biospecimen tracking system:¹

Biospecimen Identification

• Unique identifier or combination of identifiers (including number or barcode)
• Firmly affixed to the container
• Information system tracks biospecimen from collection through processing, storage, and distribution
• Data used for clinical and epidemiological
• Clear and legibly marked, able to endure storage conditions
• Shipping log tracks shipment
• Resources touching specimen
• HIPAA regulations apply for human subjects and legal requirements apply for specimens

Biospecimen Informatics

• Lab Software, hardware such as labelers, written documents, support and training necessary to annotate, track and distribute biospecimens.

Brady's specimen labeling solutions are designed to help labs adhere to CLIA and CAP regulations for tissue identification. With label printers, attachment systems, software and data collection tools, Brady's specimen labeling products are interoperable and can be integrated with existing LIS/LIMS systems. They can significantly reduce error rates and data loss, and provide chain of custody and sample date integrity.

View Brady's complete line of laboratory specimen labeling products.

^{1 Source: National Cancer Institute Best Practices for Biospecimen Resources, Prepared by: NCI, NIH, US Dept Health and Human Services, June 2007.}