[Use of elements from the ISO 90000 system in Spanish hemotherapy]

Area of Science:

• Quality Management Systems
• Blood Transfusion Services
• Healthcare Administration

Context:

• The study assessed the implementation of ISO 9000 quality management system elements in Spanish blood banks.
• The survey targeted 225 hospital-based blood banks and 25 community blood centers in November 1996.
• None of the surveyed institutions were certified under the ISO system at the time of the study.

Purpose:

• To evaluate the prevalence of all twenty ISO 9000 elements in Spanish blood banks.
• To identify which quality management practices are most and least adopted.
• To compare adoption rates between hospital blood banks and community blood centers.

Summary:

• A survey of 53 Spanish blood banks revealed widespread use of basic quality elements such as adverse reaction documentation, procedure manuals, and product traceability (over 80% adoption).
• Less commonly adopted elements (under 30% adoption) included quality units, equipment manuals, computer system validation, internal audits, purchasing criteria, and training.
• Community blood centers generally scored higher than hospital blood banks, with larger hospitals (over 500 beds) and teaching-accredited hospitals showing the best results.

Impact:

• Highlights a gap in the adoption of organizational quality management aspects within Spanish blood banks.
• Suggests a need for improved implementation of comprehensive quality systems beyond daily operational procedures.
• Provides insights into factors influencing quality management adoption, such as institution type and size.