Donor Testing-Quality Control Laboratory

The Donor Testing-Quality Control Laboratory, located in Renton, Washington, is a state-of-the-art laboratory facility that offers both high-volume and specialized Infectious Disease and Immunohematology testing services on a 24/7/365 schedule.  The Donor Testing Lab currently provides high-volume testing services for Bloodworks Northwest, and a number of other US Blood Centers, collectively testing more than 250,000 volunteer blood donors annually.  Within the 5-state Pacific Northwest Region, the Donor Testing lab also provides STAT infectious disease testing for Organ Procurement Organizations and similar testing for several Eye and Tissue Banks, local Stem Cell and Cord Blood programs, as well as several living-donor kidney transplant programs.   This lab also performs all blood component quality control testing for volunteer blood donations of Bloodworks Northwest. 

The Donor Testing Laboratory is licensed by the U. S. Food and Drug Administration (FDA), the State of Washington Department of Health, and the State of California Department of Health. Licensure by the State of Washington Department of Health satisfies CLIA certification requirements. The Donor Testing Laboratory is also accredited by the American Association of Blood Banks.

Since 2013, the Donor Testing Laboratory has been affiliated with Creative Testing Solutions (CTS) through a Management agreement.  Under the terms of this affiliation, both organizations work collaboratively on any number of quality activities, validations, etc.  CTS performs quarterly audits of the Donor Testing Lab’s operations to ensure the lab meets the same high quality standards of CTS’s three laboratories located in Tempe-AZ, Dallas-TX and Tampa-FL.  These laboratories serve as backup facilities for the Bloodworks lab, in the event of natural disaster.

The Donor Testing Laboratory’s quality assurance program encompasses: the development and maintenance of written procedures; training, continuing education and competency evaluation of staff; participation in proficiency testing programs; validation of software, hardware, equipment and procedures; and the analysis of errors and outcomes of routine audits and practices.

The Donor Testing Laboratory participates in several vendor-sponsored clinical trials each year in order to keep abreast of the latest technological advances. In addition, the laboratory is often among the first in the nation to implement newly licensed and/or required assays.

The Donor Testing Laboratory performs the following testing:

  • ABO/Rh typing
  • ABO subgrouping
  • Red cell alloantibody screening (blood donor)
  • Red cell phenotyping of Blood Donors (limited to C, c, E, e, K antigens)*
  • Syphilis by Rapid Plasma Reagin (RPR) method
  • Syphilis by anti-Treponema pallidum method
  • Total antibody to Cytomegalovirus (CMV)
  • Hepatitis B Surface Antigen (HBsAg)**
  • Hepatitis B Core Antibody (HBcAb)**
  • Hepatitis C Antibody (Anti-HCV)**
  • HIV-1/HIV-2 Antibody (Anti-HIV-1/HIV-2)**
  • HTLVI/II Antibody (Anti-HTLV-I/HTLV-II)**
  • Chagas Disease Antibody (Anti-Trypanosoma cruzi)
  • Antibody to Epstein Barr Virus Viral Capsid (EBV-VCA)
  • Antibody to Epstein Barr Virus Nuclear Antigen (EBV-NA)
  • Antibody to Toxoplasma gondii
  • Multiplex Nucleic Acid Testing (NAT) for HCV/HIV/HBV
  • Nucleic Acid testing for WNV
  • Platelet Product Counts
  • Residual WBC counts of leukoreduced blood products
  • Anti-A & Anti-B screening for Apheresis platelets

*extended phenotyping and genotyping available in other Bloodworks departments
**multiple methods available for blood vs. cadaveric donors

Confirmatory testing is performed or coordinated by the Special Studies Section of the laboratory. HLA screening (TRALI testing) is coordinated through the Donor Testing Lab and performed by the Immunogenetics (HLA) laboratory of Bloodworks Northwest.

The Donor Testing Laboratory also oversees BioBank sales of disease-state plasmas, plasmas with red-cell antibodies, and coordinates the collection and processing of paid donors for reagent manufacture by commercial vendors. 

The Donor Testing Laboratory employs a proficient staff of >30 bachelor-degreed technologists.  Key Management positions include:

Mark Bonn, MT (ASCP) – Supervisor
Sandra Hata, BS - Supervisor 
Ashley Rose, BS – Supervisor
Debra Fletcher, MT(ASCP), MBA – Operations Manager
Mark Destree, MT (ASCP), MS, MBA - Administrative Director
Rebecca Haley, MD – CLIA Director



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