Laboratory Quality Management

The primary goal of Quality Management in clinical laboratories, including blood banks and transfusion services, is to provide high quality products or services to each customer. Quality processes and procedures are put in place to assure the appropriate use of laboratory instruments and reagents, train and educate laboratory personnel and supervisors, monitor testing and correct and prevent errors.

Organizations Promoting Laboratory Quality Management

The International Organization for Standardization (ISO) 15189 is a independent, non-governmental international entity that provides standards specific for laboratory medicine. In the United States, Centers for Medicare and Medicaid Services (CMS), Clinical Laboratory Improvement Amendments (CLIA) and the Food and Drug Administration (FDA) require formal quality assurance programs for blood bank laboratories. Furthermore, professional and accrediting organizations such as the AABB (Association for the Advancement of Blood and Biotherapies), College of American Pathologists (CAP), and the Clinical & Laboratory Standards Institute (CLSI) have also established guidelines to promote the highest standards of care for patients and donors.

Principles of Quality Management in the Laboratory

Principles of quality management in the blood bank laboratory are well described in Chapter 1 of the 20th edition, AABB Technical Manual,1 including key aspects as mentioned above but also focus on the establishment of a defined structure of the organization and its leadership, careful selection of suppliers and material, process control through policies and validations, thorough documentation, controlled access to information, monitoring of quality indicators and safety of the work environment.

Continuous Process Improvement

Furthermore, continuous process improvement plays a key role in each quality program. Advancements in quality and patient safety can only be achieved through rigorous monitoring, implementation of preventive and/or corrective actions, internal and external audits, QC records as well as thorough complaint handling and follow up.