LifeSource Donor Testing Laboratory
The LifeSource Donor Testing Laboratory is one of the largest donor testing facilities in the nation. Our large volume laboratory specializes in full-service and customized testing of blood and tissue samples, resulting in the testing of more than 800,000 samples for over 90 clients each year.
The advantages of a high volume testing environment enable us to achieve competitive pricing for reagents and related supplies as well as rapid response for testing instrumentation services. These volume-driven benefits translate into cost savings for our clients.
Our laboratory has earned a strong reputation within the testing industry for service and high quality standards. More than 60 experienced medical and technical professionals strive to maintain this standing by being flexible and dedicated to meeting client needs. Their commitment to client service is demonstrated by our ability to deliver most results within 12 hours of sample receipt. And when their expertise is needed, our knowledgeable medical and technical staff is available to consult with our clients to ensure overall quality assurance.
Because our testing laboratory is an extension of our client’s facilities and their FDA licenses, our commitment to quality and compliance with regulations is driven by our corporate values and culture. Since testing is a critical process that may affect the safety, purity, and potency of blood and tissue products, FDA staff conducts an in-depth audit of our laboratory’s controls and processes every one-to-two years. Our adherence to cGMP and FDA regulations demonstrates our high quality standards.
Testing
The LifeSource Donor Testing Laboratory provides routine donor panels and/or individual tests as well as complete confirmatory, supplemental, and QC product testing. Using state-of-the art technologies, we perform required donor testing including:
- ABO/Rh Typing
- Antibody screening and identification
- Nucleic Acid Testing (NAT)
- 6 Viral Marker assays
- Confirmatory and supplemental assays
Our investments in automated technology enable us to efficiently and accurately test high volumes of blood and tissue products. The Abbott PRISM for viral marker testing and the Roche AmpliScreen and s201 Systems for nucleic acid testing along with the Olympus PK, Biotest Tango, and Biotest QuickStep are among the automated equipment utilized in our laboratory. The laboratory retains redundant instruments in the event of equipment failure.
Our Clients
We serve more than 90 clients from a wide spectrum of medical organizations including:
- Independent blood centers
- Hospital blood centers
- Cord blood banks
- HCT/P facilities
- Source Plasma facilities
- Hospital laboratories
Proficiency testing
Proficiency surveys from approved agencies such as College of American Pathologists (CAP) and American Association of Bioanalysts (AAB) are received three times a year for all analytes that are tested in the laboratory. Results are tabulated by the referring agency and reported to the laboratory.
Registrations/Certifications
Our strong regulatory compliance and adherence to high quality standards are evident by the prominent organizations and states that we are affiliated with. See our list of current registrations and/or certifications.
Registration and Accreditation Certificates
AABB Accreditation (PDF 148 KB)
FDA Registration for Donor Testing (PDF 91 KB)
FDA Registration for Tissue Testing (PDF 60 KB)
CLIA Certificate (PDF 148 KB)
European Union Certificate of Compliance (PDF 30 KB)
State of California License (PDF 142 KB)
State of Florida License (PDF 144 KB)
New York State Laboratory Permit (PDF 542 KB)
Current Assay List
View list of current assays on file.
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