Guidance for Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens

This guidance is intended to assist in the understanding and practical application of the 1st edition of the Standards for Molecular Testing for Red Cell, Platelet, and Neutrophil Antigens (MT Standards). Primarily, it contains guidance on the quality concepts that provide the framework for theMT Standards. It is also intended to serve as helpful advice or to provide examples of how to implement a specific standard. The Molecular Testing Standards Program Unit has chosen to focus this guidance document on those issues that may be least familiar to members of the molecular testing community.

Topics:

• DNA resources.
• Targeted nucleotide for neutrophil antigens.
• Equipment.
• Supplier and customer issues.
• Process control.
• Documents and records.
• Retention of records.
• Deviations and nonconformances.
• Assessments: internal and external.
• Process improvement through corrective and preventive action.
• Facilities and safety.