Vitalant Donor Center and Reference Laboratory

VITALANT - DONOR CENTER & REFERENCE LABORATORY/ VITALANT RESEARCH INSTITUTE 

GOALS:

  • Acquire the competence necessary to provide supervision of donor centers and reference laboratories.
  • Describe research topics at Vitalant Research Institute (VRI) and have an opportunity to participate in current projects or develop novel pilot studies

DIRECTOR:

Chris Gresens, MD
Medical Director, West Division
Vitalant (https://www.vitalant.org)
10536 Peter A. McCuen Blvd.
Mather, CA 95655
Phone: (916) 453-3728
Email: [email protected]

Specific Objectives:

  1. Clinical Donor Center

Donor Center and Cell Sourcing & Special Collections

  1. Understand the donor recruitment process, donor eligibility criteria, recruitment tools and blood drive process.
  2. Demonstrate understanding of donor acceptability through appropriate consultations 
  3. Describe the risks of blood donation and their management
  4. Understand storage requirements for supplies and collection equipment maintenance
  5. Review daily “bleeding order” used at Vitalant sites
  6. Understand Vitalant Special Donations Program - autologous collections, directed collections, and therapeutic collections
  7. Understand the interactions Vitalant has regarding cell collection for further manufacture of  immunotherapy products (FDA approved and research if applicable)
  1. Describe criteria for accepting donors for research apheresis protocols
  2. Observe apheresis procedures for collection of mononuclear cell products for research

Reference Laboratory

  1. Describe the major surface antigens of red blood cells (genetics, biochemical properties and known physiologic function)
  2. Recognize properties of antibodies against RBC antigens, including clinical significance 
  3. Describe the techniques for detection of antigens, antibodies and complement on the red cell membrane.
  4. Assist Medical Directors and Reference Lab Staff in consultation with hospitals re: patients with complex antibody issues.  Review IRL reports with Medical Directors
  5. Discuss the nomenclature of platelet-specific antigens and current techniques used to type them
  6. Recognize the role of these antibodies in neonatal alloimmune thrombocytopenic purpura and post-transfusion thrombocytopenic purpura
  7. Assist Medical Directors and Reference Lab Staff in consultation with hospitals re: patients with NAIT and platelet refractoriness 

Quality Assurance and Medical Affairs

  1. Review the basic principles of GMP
  2. Be familiar with the relevant requirements of CFR series 200 and series 600, AABB Standards and relevant requirements of the State of California
  3. Review the Vitalant Deviation Management System and auditing techniques 
  4. Outline requirements for returning to inventory components sent back from the hospitals
  5. Understand how orders are received and filled
  6. Describe procedures to be followed when a report is received about a transfusion-associated infection or transfusion adverse reaction
  7. Review the regulatory requirements for look back, procedure for responding to post donation information and donor re-entry protocol
  8. Assist the Medical Directors with consultation to Vitalant staff regarding donor questions,  management of donor reactions, transfusion adverse events, including donor investigations and writing of the final consult note, transfusion associated infections including donor investigations and writing of the final consult notes
  9. Assist Medical Directors in Evaluation of post-donation information, market withdrawals and recalls