Chapter 13

1. Chapter 13 Donor Screening and Component Preparation

2. Governing Agencies • Governing agencies for processes including donor selection and donor unit processing • U.S. Food and Drug Administration (FDA) • Center for Biologics Evaluation and Research (CBER) • American Association of Blood Banks (AABB) • College of American Pathologists (CAP)

3. Donor Screening • Donor screening encompasses the donor medical history, mini physical examination, and serologic testing of the donor blood. • Donor identification and registration requirements to confirm donor identity and link the donor to existing donor records • Consent to donate • Additional information

4. Donor Screening (cont’d) • Reasons for donor screening • Ensuring safety of the donation for the donor • Obtaining donor blood that will not transmit disease to the potential recipient

5. Medical History Questionnaire • A standardized medical history questionnaire was developed by a task force that included representatives from AABB, FDA,and the blood and plasma industry. • Self-administered questionnaires must be reviewed by trained personnel prior to blood collection.

6. Donor History Questionnaire (DHQ) • The currently approved version of the Donor History Questionnaire (DHQ) can be downloaded from the FDA website.

7. The Physical Examination • The donor center representative evaluates the prospective donor with regard to • General appearance • Weight • Temperature • Pulse • Blood pressure • Hemoglobin • Skin lesions

8. Informed Consent • AABB Standards mandates that informed consent of allogeneic, autologous, and apheresis donors be obtained. • The donor must be informed of the risks of the procedure and also of the tests that are performed to reduce the risk of infectious disease transmission to the recipient.

9. Autologous Donors • Most autologous blood is used to treat surgical blood loss in very specific situations where there is a reasonable opportunity to avoid homologous transfusions and/or when compatible allogeneic blood is not available. • Advantages include decreased risk of disease transmission, transfusion reactions, and alloimmunization.

10. Autologous Donors (cont’d) • Disadvantages of autologous donation/transfusion beyond the usual risks • Bacterial contamination • Circulatory overload • Cytokine mediated reactions and product/recipient misidentification

11. Methods for Obtaining Autologous Blood • Preoperative collection • Acute normovolemic hemodilution • Intraoperative collection • Postoperative collection

12. Directed Donation • A directed donation is collected under the same requirements as allogeneic donors, but is directed toward a specific patient. • The tag for the directed unit is a distinct color. • If the donor is a blood relative, the unit must be irradiated to prevent GVHD. • A system should be in place to ensure directed units from blood relatives are irradiated.

13. Apheresis Collection • A means for collecting a specific blood component while returning the remaining whole blood components back to the patient. • Blood separated into components with centrifugal force based on differences in density. • Can be used to collect large volumes of the intended component, such as platelets, plasma, white cells, red cells, and stem cells.

14. Apheresis Collection (cont’d) • Donor requirements are generally the same as for whole blood donation, although time intervals between donations can vary depending on the component collected. • The process is regulated by the FDA. • The AABB and the American Society for Apheresis (ASFA) provide standards.

15. Whole Blood Collection • Once the donor has satisfied requirements of the screening process and has been registered, whole blood collection proceeds. • Donor identification • Aseptic technique • Collection procedure • Post-donation instructions

16. Donor Reactions • Reactions can be divided into three categories • Mild reactions • Moderate reactions • Severe reactions • The donation center staff should also be prepared to properly treat hematomas.

17. Donor Records • Donor records must be retained by the blood collection facility as mandated by the FDA and AABB. • There must be a system to ensure that confidentiality of the donor is not compromised, and that donor records are not altered.

18. Donor Processing • The processing tests performed on donor blood include the following • ABO/Rh • Antibody screen • HBsAg • Anti-HBc • Anti-HCV and NAT

19. Donor Processing (cont’d) • Anti-HIV-1/2 and NAT • Anti-HTLV-I/II • WNV RNA • Syphilis • T. Cruzi (Chagas Disease) • Platelet bacterial detection

20. Component Preparation • A single blood donation can provide transfusion therapy to multiple patients in the form of RBCs, platelets, fresh frozen plasma, cryoprecipitate, and other components. • The AABB Standards address the preparation, quality indicators, and storage requirements for all component products.

21. Component Preparation (cont’d) • Whole blood • Irradiated whole blood • Rationale for limited number of whole blood units • Red blood cells • RBC aliquots

22. Component Preparation (cont’d) • RBCs irradiated • RBCs leukoreduced • Frozen, deglycerolized RBCs • High glycerol (40% weight per volume) • Low glycerol (20% weight per volume)

23. Component Preparation (cont’d) • Platelet concentrates • Platelet aliquots • Platelets leukoreduced

24. Component Preparation (cont’d) • Single-donor plasma • Thawed plasma and liquid plasma • Cryoprecipitated antihemophilic factor

25. Plasma Derivatives • Plasma derivatives are different from blood components because they are prepared by further manufacture of pooled, human source and recovered plasma. • Recombinant DNA technology or monoclonal antibody purification may also be utilized in their preparation.

26. Plasma Derivatives (cont’d) • Source Plasma is defined as plasma collected by plasmapheresis and intended for further manufacture into plasma derivatives. • Recovered Plasma is plasma recovered from whole blood donations that is shipped frozen to a manufacturer. • Cryoprecipitate is separated from the plasma and used for the production of Factor VIII concentrate.

27. Plasma Derivatives (cont’d) • The residual plasma is then separated into various proteins by manipulating the pH, alcohol content, and temperature. • These products then undergo viral inactivation by any of several methods, including heat, solvent-detergent treatment, and nanofiltration.

28. Activated Factor VII (Factor VIIa) • Produced by recombinant DNA technology for • Patients with Hemophilia A who have circulating antibodies/inhibitors to Factor VIII • Patients with congenital Factor VII deficiency • Trauma, massive transfusion, and liver transplantation • Uncontrolled non-surgical hemorrhages after implantation of VAD (ventricular assist devices)

29. Factor VIII Concentrates (FVIII) • Used to treat patients with Hemophilia A or classical hemophilia • Have almost completely replaced cryoprecipitate as the product of choice • May be prepared from large volumes of pooled plasma • More commonly prepared by recombinant DNA technology

30. Factor VIII Concentrates (FVIII) (cont’d) • If prepared from pooled plasma to inactivate or eliminate viral contamination • Pasteurization • Solvent/detergent treatment • Monoclonal antibody purification

31. Porcine Factor VIII • The xenographic form of Factor VIII is made from porcine plasma. • Beneficial for patients with Hemophilia A with inhibitors or antibodies to human Factor VIII.

32. Recombinant Factor VIII • Produced by introducing human FVIII gene (rFVIII) into baby hamster kidney cell lines, followed by purification and final formulation.

33. Factor IX Concentrates • Developed by monoclonal antibody purification • Available in three forms • Prothrombin complex concentrates • Factor IX concentrates • Recombinant FIX

34. Factor XIII Concentrates • Two plasma-derived virus inactivated factor XIII concentrates • An investigational new drug in the U.S. • A “named patient” basis drug in the U.K.

35. Immune Serum Globulin • A concentrate of plasma gamma globulins in an aqueous solution • Indicated for a variety of patient conditions

36. Normal Serum Albumin (NSA) • Prepared from salvaged plasma, pooled and fractionated by a cold alcohol process, then treated with heat inactivation • Available in 25% or 5% solutions • Indicated for a variety of patient conditions

37. Plasma Protein Fraction (PPF) • Preparation similar to that of NSA, with fewer purification steps • Indicated for a variety of patient conditions

38. Rho(D) Immune Globulin (RhIg) • A solution of concentrated anti-Rho(D) • Prepared from pooled human plasma of patients who have been hyperimmunized and contains predominantly IgG anti-D • Treatment of ITP and prevention of Rh HDN • Dosage and administration recommendations in prevention of Rh HDN

39. Synthetic Volume Expanders • There are two categories of synthetic volume expanders: crystalloids and colloids. • Ringer’s lactate and normal isotonic saline comprise the crystalloids • Dextran and HES make up the colloid solutions • These solutions are useful in burn patients and in cases of hemorrhagic shock.

40. Antithrombin III Concentrates, Antithrombin (AT) • Prepared from pooled human plasma and heat-treated • Indicated for patients with hereditary AT deficiency in connection with surgical or obstetrical procedures or when they suffer from thromboembolism • A new recombinant AT concentrate (rhAT) produced using transgenic technology has been developed on a compassionate-use basis.

41. Labeling of Components • Components must be labeled in accordance with AABB Standards, FDA regulations, and International Society of Blood Transfusion (ISBT) Code 128 requirements. • Donor Identification Number (DIN), product/donor linking, and labeling requirements for volunteer and autologous components