Blood Donation Deferral Criteria

Donor Screening

• Donors must register their information accurately, including name, date/time of donation, address, contact number, gender, age, and birthdate
• A medical history questionnaire and physical exam are required, covering general appearance, weight, temperature, pulse (50-100 bpm), blood pressure (less than 180/100 mmHg), hemoglobin (12.5-15 g/dl), and skin lesion check

Donor Deferment

• Donors with a history of viral hepatitis, (+) HBsAg, reactive for Anti-HBc, past/present Hepatitis C evidence, post-transfusion hepatitis, jaundice of unknown cause, self-injected drug abuse, cancer, or abnormal bleeding are indefinitely deferred
• Also deferred are those with cardiopulmonary diseases, leukemia, lymphoma, high-risk sexual behavior, high-risk occupation, Chaga's disease, babesiosis, or active pulmonary TB
• Donors taking Tegison for psoriasis (teratogenic) or receiving human pituitary growth hormone (risk of Creutzfeldt-Jakob disease) are permanently deferred
• Individuals with AIDS Related Complex (ARC) or HIV/AIDS (persistent night sweats, fever for >10 days, weight loss) are also deferred
• A three-year deferral is given to those infected with malaria and visitors/residents of malaria-endemic areas
• A twelve-month deferral applies to donors with hepatitis contact, those who received blood/products, organ/tissue transplants, tattoos, ear/skin piercing, HBIg recipients, or those treated for syphilis/gonorrhea
• (+) serologic test for syphilis, donors who have traveled to areas considered endemic for malaria (don't defer a donor who started antimalarial therapy in preparation travel to areas endemic for malaria), sexual contact with any person who has high risk of exposure to HIV, and surgical procedure (major/minor)
• Rabies vaccine recipients (following the bite of a rabid animal) also get a year deferral
• A two-month (8 weeks/56 days) deferral applies to donors after a whole blood donation
• Pregnant women are deferred for 6 weeks following a third-trimester delivery; 1st and 2nd trimester abortions/miscarriages don't cause deferral
• Donors taking Accutane are deferred for one month (4 weeks), as are those who received vaccines for Rubella or Varicella zoster
• A two-week deferral is given after attenuated virus vaccines for mumps, oral polio, rubeola, smallpox, yellow fever, and influenza (live virus)
• A three-day deferral is given for those who have had a tooth extraction or dental work with recent aspirin intake (evaluated for platelet pheresis)
• Donors in apheresis programs must wait 48 hours to donate again; those who consumed alcoholic beverages must wait 24 hours
• Those with cold/flu symptoms must wait until symptoms are gone
• Vaccinations for killed viral, bacterial, rickettsial vaccines or toxoids like diphtheria, tetanus, cholera, Hepa B vaccine, pertussis, typhoid, RMSF, influenza (killed), injectable polio vaccine (Salk) don't cause deferral

Post-Donation Testing

• Collected blood units are tested for ABO/Rh, antibody screen, HBsAg, Anti-HBc, Anti-HCV, NAT for HIV 1/2 , West Nile Virus RNA, Anti-HTLV I/II, and Syphilis
• ABO blood group testing requires both forward and reverse grouping; RhD negative results require AHG phase confirmation

Antibody Screening

• Antibody screening should be performed by AHG, and donors with a positive antibody screen should be deferred.

HBsAg Testing

• The test procedure must be approved by the FDA.
• Approved methods include radioimmunoassay (RIA), enzyme-linked immunosorbent assay (ELISA), and reverse passive hemagglutination (RPHA).

Anti-HBc Testing

• All HBsAg negative results should be confirmed by Anti-HBc using approved methods.

Anti-HCV and NAT Testing

• Use FDA-approved enzyme immunoassay (EIA) parallel with NAT
• The recombinant immunoblot assay (RIBA) or NAT should be used to confirm positive serological results.

Anti-HIV 1/2 Testing

• The test procedure must be approved by the FDA and all positive results must be confirmed with Western blot and NAT

Important Considerations for Donors

• Allogeneic blood donors must weigh over 110 lb (50 kg)
• The pulse rate for blood donors should be between 50 and 100 beats per minute.
• Hemoglobin/hematocrit level of allogeneic blood donors must be at least 12.5/38%
• Donors are permanently deferred with a confirmed positive HBsAg test after the 11th birthday
• The deferral period for those who have been treated for malaria is 3 years following therapy
• Those who have had a blood transfusion are deferred for 12 months due to potential exposure to hepatitis, HIV, or other viral diseases
• Platelet pheresis donors shouldn't take aspirin for 3 days before donation due to platelet function effects
• The minimum interval between whole blood donations is 8 weeks or 56 days
• Individuals with a history of hemophilia A/B, von Willebrand disease, or severe thrombocytopenia are permanently barred from donating
• Attenuated live viral vaccines (smallpox, measles, mumps, yellow fever, influenza) have a two-week deferral
• German measles (rubella) and chickenpox (varicella zoster) vaccines have a 4-week deferral
• Blood donors with a positive serologic test for syphilis are deferred for 12 months
• Those who have tested positive for the HIV antibody are indefinitely deferred

Autologous Donation

• Refers to blood for the donor-patient drawn before an anticipated transfusion (e.g., surgery) and stored for use
• Autologous donors must have hemoglobin of at least 11 g/dL and a hematocrit level of at least 33%

Intraoperative Autologous Transfusion

• Blood collection during surgery with immediate reinfusion

Acute Normovolemic Hemodilution

• 1-3 units of whole blood collected in the operating room, patient volume replaced with colloid/crystalloid; blood is reinfused during surgery

Postoperative Salvage

• Autologous donation where a drainage tube is placed in surgical site, postoperative bleeding is salvaged, cleaned, and reinfused

Blood Storage

• Whole blood units should be stored at 1°C to 6°C; platelet production units should be stored at 20°C to 24°C until platelets are removed

Blood Component Testing

• Donor units must be tested for viral markers: STS, anti-HIV-1/2, HIV-antigen, anti-HTLV I/II, HBsAg, anti-HBC, and anti-HCV
• RBCs must be prepared to separate them from plasma, with a resulting hematocrit of ≤80%
• Irradiated RBCs must get a radiation dose of ≥25 Gy to midplane of canister with expiration date changes to 28 days post-irradiation if that comes before the original outdate
• Leukocyte-reduced RBCs have an absolute leukocyte count of <5 x 10^6

Platelet Requirements

• Random-donor platelets must contain ≥5.5 x 10^{10} platelets; single-donor platelets must contain ≥3 x 10^{11} platelets; shelf-life is 5 days

Fresh Frozen Plasma

• FFP must be prepared within 8 hours of collection for CPD, CPDA-1, CP2D, and stored at -18°C for 12 months

Cryoprecipitate Requirements

• Prepared from FFP, contains ≥80 units of antihemophilic factor and 150-250 mg of fibrinogen; used for hemophilia A, factor XIII deficiency, and hypofibrinogenemia

Rh Immune Globulin

• Concentrated anti-Rh_0(D) from pooled hyperimmunized donor plasma, prevents Rh_0(D) immunization in Rh-negative mothers post-abortion, miscarriage, amniocentesis, or delivering Rh-positive/Rh-unknown infants
• One random-donor platelet unit typically increases the platelet count in a 70-kg adult by 5,000-10,000/μL; one apheresis platelet unit should increase the platelet count in a 70-kg adult by 30,000-60,000/μL

Blood and Components

• Blood and its components are considered treatment and drugs

Transfusion Therapy

• Used to treat inadequate oxygen-carrying capacity due to anemia or blood loss and insufficient coagulation proteins or platelets, with the ultimate goal of providing adequate hemostasis

Whole Blood

• Composed of RBCs (Hct: 40%), plasma, WBCs, platelet 'not function “, anti-coagulant (63 ml to 70 ml to 450 +- 45 ml or 500 + - 50 ml of whole blood)
• WB expires in 21-35 days based on the preservative used
• Used to replace both RBC and plasma loss in rapidly bleeding patients with a labile Factor V and VIII deficiency
• One unit of WB can increase Hct by 3-5% and Hgb by 1-1.5 g/dL for 48-72 hours
• Primarily used for autologous transfusion
• Any unit less than 405 up 300 ml is considered as W.B. Additive solution

Packed Red Blood Cells

• Has approximately 75%(70-80%) Hct or approximately Hct 55-60% with A.S, reduced plasma, WBC, platelets and anticoagulants. PRBC volume is 300 ml + - 50 ml
• PRBCs expiry is 21-35 depending on the preservative but with A.S. the expiry will be 42 days
• Increases hemoglobin and hematocrit more rapidly/efficiently than whole blood
• Used to treat surgical and leukemic patients with low hemoglobin levels; also, for patients with lung or cerebral vascular disease
• Not recommended for nutrition anemia (iron deficiency or pernicious anemia)

Advantages of PRBCs

• Equal oxygen capacity in half the volume, reduced level of significant antibody (anti-A & anti-B),reduced risk of transfusing O group to non O group, reduces levels of acid,citrate and potassium causing toxicity and cardiac/renal/liver disease

Washed RBCs

• Free of plasma protein components and are indicated for patients with anaphylactic reaction or IgA deficiency

Leukocyte- Reduced RBCs

• Contain fewer platelets and RBCs, with WBCs between 5 X 10^6 and 5 X 10^8
• Indicated to reduce risk of febrile non-hemolytic transfusion reaction, Human leukocyte antigen alloimmunization, (TRALI), (TA-GVHD), transmission of cytomegalovirus, Epstein – Barr virus (EBV), HIV, HTLV

Coagulation disorders

• Haemophilia A is a deficiency of Factor VIII, results in a prolonged APPT and low factor VIII. Managed with F VIII concentrate
• Controlling spontaneous bleeding requires F VIII>20%. Major surgery and trauma require higher levels
• Haemophilia B is a deficiency of Factor IX, results in a prolonged APTT and low factor IX. Managed with F IX concentrate
• Von Willebrand's disease (VWD) involves abnormal platelet adhesion and low Factor VIII and VWF activity, prolonged bleeding time. Treated with FVIII with vWF.

Acquired Coagulation disorder

• Vitamin K deficiency is due to its fat soluble nature, and is present in green vegetables and is bacterial is synthesized in the gut. Treat with Prophylaxis of vitamin K.
• Warfarin acts as VK antagonists reducing the functional activity of F II, VII, IX, X, proteins C and S, showing prolonged PT and APTT
• FFP if there hemorrhage is sever Liver disease involves disseminated intravascular coagulation. Common causes of DIC are infections, malignancy, and obstretic compliactions. This shows a Low platelet count, low level of fibrinogen, prolongs TT, and increase level of fibrinogen degradation products

Acquired Bleeding Disorders testing:

• Prothrombin Time - PT - screens for deficiencies in Factors VII, X, V, prothrombin and fibrinogen. Normal range 10 - 14 sec.
• Activated Partial Thromboplastin Time -APTT - Screens for deficiencies in Factors VIII, IX, XI, XII, prothrombin and fibrinogen. Normal range 30-40 sec.
• Thrombin Clotting Time - TT - Detects deficiencies in fibrinogen or inhibition of thrombin. Normal range 14-16 sec.

Key Hemostatic Factors

• Fibrinogen
• Prothrombin
• Tissue Factor
• Labile Factor
• Proconvertin, factors VIII, IX, X, XI, and XII

Activation of the Pathway of Blood Coagulation by Tissue Factor (TF) on a Cell Surface

• Plasma coming into contact with TF causes factor (F) VII binds to TF, TF and activated VII (VIIa), TF pathway inhibitor (TFPI), production of thrombin from prothrombin
• Thrombin leads to fibrin formation

Hemostatic and Blood Vessel Function

• Key functions of the blood vessel include platelet‐subendothelium adhesion, carriage of VIII, and inhibition of blood coagulation.

Hemostatic Function

• Blood count and blood film examination
• bleeding time detects abnormal platelet function Screening tests include examination of the activated partial thromboplastin time, the thrombin clotting time, and the the prothrombin time

Hemostasis and Platelets.

• Vessel injury leads to platelet and tissue factor release, activating mechanisms to reduce blood flow and to allow for platelet fusion to form a stable homostatic plug

Coagulopathy Treatment

• FFP (Fresh Frozen Plasma) prepared from whole blood (target collection time of 4-10, minimal trauma) or through aphaeresis collection, and then is used to replace multiple coagulation factors in patients after a deficiency

FFP treatment and storage

• Contains all coagulation factors" and is therefore used in multiple coagulation deficiencies.
• FFP for treatment: 1mL of FFP→ contain lunit with [(1 IU/ml) labile] of multiple factors. A unit of FFP is defined by activity in 1ml pooled normal plasma at 100% activity in 1 unit per unit.
• Thawed FFP that is stored within 24 hours should be transfused, otherwise should be stored at 1-6°C for < 5 days.
• Stored at -18°C

Methods of FFP Storage and Treatment:

• Thawing
• Solvent treatment to removed coagulation factors or unwanted properties

Plasma Contents

• Consists of all the plasma and labile contents, or all the plasma content lacking labile factors. If plasma prepared/stored with WB, contents can be used for 5 years but only 5 days if simply used.

Solvent treatment to remove cryoprecipitate from plasma to generate a product exclusively used for treatment of TTP. Pooling solvents/detergents to remove blood types from a list of plasmas, while freezing to preserve factors

S/D Plasma

• Contains the standard amount of factors and is used to treat pregnant women

Blood Management

• Massive Transfusion management: Replacing coagulation factor can achieve homeostasis with with approximately 10-15% factor V levels.
• A treatment of antithrombin that is designed to be the reverse of heparin, and to treat factor XI deficienies

Platelet Transfusion Therapy: Platelets for form a haemostatic plug or fibrin and is used in relation to medical history

Adhesion: PLT Adhesion to damaged endothelium by the von willebran factor

• The normal platelet count is 150 -400 X109/L and the mean platelet diameter is 1-2um

Platelet Deficincies

• Thrombocytopenia: results and becomes dysfunctional if platlets count is less than < 150,000 /uL.
• Conditions of low platelet counts include: viral infection of malaria, drug induced reactions, or DIC (disseminated intravascular coagulation)

Factors in Transfusion

• Bleeding during thrombocytopenia requires tranfusion to remain at a level of 5000/ul
• Treatment may include: maintaining levels, increasing levels, and affecting malfunctions

Proper Platelet Management techniques:

• Irradiation
• Platelets removed
• Refractoriness, matched platelets

Important Factors in Blood Transfusion

• ABO antigens do not carry the D antigen (negative RBCs), and if these are missing in the patient, (10ug for one Rh D positive unit) should be administred.
• Select group-specific blood type can be selected for babies, and resuspension with saline or albumin or AB plasma/

RBCs, plasma, and platelet requirements

• The platelet count should be more than 5.5 X10
• The volume of the plasma should be less than 60-50mL
• The pH at the expiration should be more than 6.2
• Stored in agitators (20-24C)

Blood preparation

• Factor VIII can can be extracted from plasma and made safe for use
• Factor IX can be prepared to be used for use

Thawing Plasma and Blood

• FFP are simply alternative sources of antithrombin I, or proteins to treat coagulation disorders (C or S)
• Albumin may simply be from albumin and other sources
• Immune globulin is created fro multiple and disease specific sources

Leucocytes

• Leucocyte reduction filters remove leukocyte from RBCs and platelet products.
• Negative CMV in the blood

General Notes

• Blood volume/plasma, platelets can have an effect on the transfer in terms of compatibility. When they dont, it is often related to hemolysis of the donor.
• Cell products must be irradiated for people with genetic abnormalities
• The amount of each type must be calculated from the correct increment of change per person
• Rapid transfusion and patients with Paroxysmal Cold Hemoglobinuria or cold agglutinins may require blood warming. Only isotonic 0.9% saline or 5% albumin should be used to .dilute blood components, and also in regards to the hospital and staff

Emergency Factors

• Fever with back pain may be due to acute hemolytic transfusion reaction
• Anaphylaxis, hives or pruritus may be an urticarial reaction
• The need to review conditions after a transfusion

Treatment Methods

• Use of RBCs when low on hemoglobin or volume
• Platelets as required per patients
• FFP on liver failure, DIC, and K deficiency