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FDA circular 1
Blood and blood products
| Question | Answer |
|---|---|
| Transfusion transmitted disease tests performed on each blood donation | HIV: ab and NAT, HCV: ab and NAT, HBV: ab-HBCAg, HBSag, NAT, Syphilis, HTLVI/II-abs, WNV NAT, Chagas ab- once for life of donor (Babaesia is regional NAT;14states and DC) Malaria update 2025 |
| Transfusion transmitted disease tested for once in a donor's lifetime | Chagas ab |
| When is testing is required for autologous units? | If collected in same facility: no required testing. If collected in another facility: first unit and same testing every 30 days. |
| If a blood product does not have an expiry on the label, when does it expire? | midnight |
| When does a platelet product expire AFTER being washed? | 4 hours |
| When does a RBC expire AFTER being washed? | 24 hours |
| Please list all medications approved for administration in the same line with blood products. | none |
| List IV fluids compatible with blood products. | normal saline |
| First step in managing a transfusion reaction. | stop the transfusion |
| A transfusion must be completed within this timeframe | 4 hours |
| Definition of febrile non-hemolytic reaction (FNHTR) | temperature rise of >1 degree C during or within 4 hours of transfusion with no other symptoms |
| This blood product modification reduces the incidence of FNHTRs. | leukoreduction |
| Most common cause of an anaphylactic transfusion reaction. | unknown |
| Blood product modification that can help prevent anaphylactic transfusion reactions in patients with a h/o that reaction. | washing cellular products |
| Definition of TRALI. | non-cardiogenic pulmonary edema within 6 hours of transfusion with hypoxemia without underlying lung disease or heart failure |
| Pathogenesis of TRALI. | predominantly, HLA-abs in donor plasma opsonize WBCs in recipient. The WBCs get stuck in pulmonary capillaries and release their contents causing damage. |
| How is the risk of TRALI mitigated? | 1. prefer male donors for high plasma content products 2. test female donors who report a h/o pregnancy for HLA antibodies |
| How is TRALI treated? | supportive care including mechanical ventilation and oxygen. Steroids are not evidenced based. |
| Why are TRALI reactions reported to the blood bank? | So co-components can be quarantined. |
| What is post-transfusion purpura (PTP)? | thrombocytopenia 7 to 10 days after transfusion. Most cases are self limited. |
| What is the treatment of PTP? | IVIG |
| What is TA-GVHD? | Transfusion associated graft versus host disease. |
| Explain pathogenesis of TA-GVHD. | T-cells in transfused cellular products attack and engraft in host tissues. |
| What is the blood product modification which can help prevent TA-GVHD? | irradiation |
| What patient groups are at greater risk for TA-GVHD? One specific group that is not at risk. | patients with defective cell mediated immunity are at risk (Digeorge's, fludarabine, SCID, BMT, hematologic malignancies). HIV patients are not at risk. |
| What is the dose of gamma irradiation delivered to the central portion of a blood product bag? | 2500cGy |
| What is the dose of gamma irradiation delivered to the corner portions of a blood product bag? | 1500cGy |
| What % of blood donors are CMV positive? | up to 70% |
| Describe 3 methods to reduce risk of transfusion transmitted CMV. | leukoreduction, pathogen reduction, CMV seronegative products |
| Blood product most frequently implicated in a septic transfusion reaction. | platelets |
| List organisms causing septic transfusion reactions by blood product. | platelets: skin contaminants (staph, strep) RBCs: Yersinia enterocolytica |
| Why is it very important to report any febrile reaction to the blood bank? | If it is a septic transfusion reaction, co-components need to be quarantined |
| Describe TACO including pathogenesis and treatment. | fluid overload in transfusion setting. Diuretics |
| Describe “citrate toxicity” including metabolism, electrolytes | citrate is the anticoagulant in blood units. In high doses it can cause hypocalcemia. Perioral and distal extremity numbness and tingling are reported |
| How are fatal transfusion reactions reported? Who? What? When? How? | ASAP by fax or phone to CBER at FDA. Written report within 7 days. |
| Qualifying hematocrit for an autologous blood donor. | 33% |
| Shelf life of RBCs by anticoagulant: ACD-A? AS-5? CPD? CPDA-1? CP2D? | ACD-A = 21 AS-5 - 42 CPD =21 CPDA-1= 35 CP2D =21 |
| Hematocrit of an RBC unit stored in AS-1. | 55% to 65% |
| Amount of residual plasma in a RBC unit | 20 to 100 ml |
| Indications for RBC transfusion | symptomatic anemia, RBC exchange |
| Contraindications to RBC transfusion | don't treat iron deficiency, B12 or folate deficiency with RBCs. don't use RBCs for volume expansion |
| Average bump in hemoglobin after a one unit RBC transfusion | 1 gm/dL |
| Compatibility requirements for: Whole Blood? RBC units? | whole blood: exact RBCs: cells compatible with patient serum; so O is universal donor |
| 45. What RBC units may be used emergently (prior to complete crossmatch)? | uncrossmatched group O RBCs |
| 46. Most common cause of severe hemolytic transfusion reactions. . | clerical errors; misidentification of patient |
| 47. Describe the workup of a hemolytic transfusion reaction | 1. stop the transfusion 2. clerical check 3. post transfusion sample for testing 4. return remainder of unit to blood bank |
| 48. List signs and symptoms of an acute hemolytic transfusion reaction | FEVER tachycardia, blood pressure changes, shock, pain, bleeding |
| 49. What is a delayed hemolytic transfusion reaction? | evanescent antibody has an amamnestic response on re-exposure. 2 to 14 days after transfusion. hemolysis with +DAT. Most have a benign course. |
| 50. Describe the hyperhemolysis syndrome. | in sickle cell patients, sometimes hemolysis occurs without an antibody. Even autologous RBCs are lysed. Rx: IVIG |
| 51. Briefly outline all of the human body’s physiologic pathways for eliminating excess iron. Stop at the molecular level listing genes, but do not iterate all nucleotide base pairs. | none |
| 52. List non-immune causes of hemolysis | mechanical valves, small bore IV for blood transfusion, hypotonic fluids, medications, bacterial toxins, thermal injury |
Created by:
jfshikle
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