Quality Assurance in Tissue Resources Supporting Biomedical Research

Area of Science:

• Biomedical Research
• Tissue Science
• Quality Management

Background:

• Biomedical research necessitates high-quality human tissue specimens.
• Various organizations supply human tissues through diverse operational models.
• Effective quality assurance and control are paramount for research specimen integrity.

Purpose of the Study:

• To review current quality assurance (QA) and quality control (QC) concepts in human tissue supply organizations.
• To discuss proposed new approaches in QA and QC for research tissues.
• To highlight the importance of QA/QC for reliable biomedical research.

Main Methods:

• Review of existing organizational models for human tissue collection and supply (prospective collection, tissue banking, clinical trial-associated collection, integrated tissue resources).
• Analysis of quality assurance (QA) and quality control (QC) practices within these models.
• Examination of established and proposed QA/QC strategies.

Main Results:

• Multiple models exist for supplying research tissues, each with distinct goals.
• All tissue supply models must implement strong QA and QC programs.
• The UAB Tissue Collection and Banking Facility exemplifies a long-standing program with established QA/QC.

Conclusions:

• Robust QA and QC are essential for all organizations providing human tissues for research.
• Established models for human tissue supply can guide the development of animal tissue programs.
• Continuous improvement and adoption of new QA/QC approaches are vital for advancing biomedical research.