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Related Experiment Videos

Quality assurance in thrombapheresis.

S P Hauser1, M Schaller, U E Nydegger

  • 1Central Hematology Laboratory, University Hospital Bern, Switzerland.

Transfusion Science
|January 6, 2000
PubMed
Summary

Three apheresis systems were evaluated for platelet apheresis (PCA) performance. All systems demonstrated consistent product quality with low residual white blood cells (WBCs), ensuring adherence to national guidelines.

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Area of Science:

  • Transfusion Medicine
  • Blood Banking Technology
  • Apheresis Science

Background:

  • Comprehensive quality systems necessitate adherence to current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP) in apheresis units.
  • Standard Operating Procedures (SOPs), flow charts, and operator training are crucial for documenting and ensuring quality in apheresis operations.

Purpose of the Study:

  • To systematically evaluate and compare the performance of three different cell-separator systems used for platelet apheresis (PCA).
  • To assess product quality, specifically residual white blood cell (WBC) content, and identify any significant differences between the systems under daily working conditions.

Main Methods:

  • Performance testing of three cell-separator systems (CS-3000 plus, AS-104, Spectra with LRS) using 10 platelet apheresis procedures per system.
  • Adherence to established Standard Operating Procedures (SOPs) and daily working conditions.
  • Collection of data on processed blood volume and residual white blood cell (WBC) content per apheresis product.
  • Monitoring for transfusion-related side effects via post-procedure questionnaires.

Main Results:

  • Few significant performance differences were observed between the three apheresis systems, with variations often linked to processed blood volume.
  • No significant difference in residual white blood cell (WBC) content per bag was found across the systems.
  • The AS-104 and Spectra systems consistently yielded products with < 1 x 10^6 WBCs per bag; the CS-3000 system also largely met this criterion (9 out of 10 bags).
  • No transfusion-related side effects were reported during the study.

Conclusions:

  • Platelet apheresis systems, when operated under SOPs and with thorough record-keeping, ensure consistent product quality meeting national guidelines.
  • The evaluated apheresis systems demonstrate comparable efficacy in producing high-quality platelet products with low WBC contamination.
  • Systematic evaluation and documentation enhance operator motivation and reinforce adherence to quality standards in apheresis centers.

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