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BBTM1
TM chap 1-5
Question | Answer |
---|---|
Discovered ABO blood group | Landsteiner |
Risk of transfusion transmitted HIV | 1 in 2,000,000 |
This process reduces risk of TA-GVHD | irradiation |
This process reduces risk of FNHTR | leukoreduction |
how often do blood bank procedures have to be reviewed | at least every other year |
The primary regulator of blood banks | FDA |
Does FDA consider blood a drug or a biologic? | both |
This part of CFR regulates drugs | Part 200 of CFR |
This part of CFR regulates biologics | Part 600 of CFR |
title 21 CFR Part _?_ addresses FDA registration and licensure for blood centers | Part 607 |
when is licensure required for blood collection facilities? | when you ship across state lines |
This form is presented by FDA when they arrive for an inspection | 482 |
how often does FDA inspect blood banks? | every 2 years |
This form is presented by FDA with their findings when they finish an inspection | 483 |
In what parts of 21 CFR are cGMPs found related to blood banks? | 211 (drugs) and 606 (biologics) |
What is the most common FDA citing in an inspection? | failure to follow SOPs |
How often does FDA inspect a therapeutic apheresis service? | never. therapeutic apheresis is the practice of medicine and does not fall under FDA |
how old do you have to be to donate blood? | 17 or some states allow 16 with parental permission |
minimal weight for a blood donor | 110 pound (50 kg) |
donation interval for whole blood | 56 days |
donation interval for double red cell automated donation | 112 days |
donation interval for infrequent plasmapheresis | 28 days |
donation interval for platelets | > or =2days |
minimal hemoglobin for donors | 12.5g/dL female; 13g/dL male |
heart rate range for donors | 50-100bpm; <50 acceptable if otherwise healthy |
acceptable temperature for donors | < or =37.5 |
deferral period for Tegison | indefinite |
deferral period for bovine insulin | indefinite |
deferral period for Acitretin (Soriatane) | 3 years |
deferral period for Dutasteride (Jalyn, Avodart) | 6 months |
deferral period for finesteride (proscar, propecia) | 1 month |
deferral period for Isoretinoin ( Accutane) | 1 month |
deferral period for aspirin | 2 days if sole source of platelets |
deferral period for Piroxicam (feldene) | 2 days if sole source of platelets |
deferral period for prasugrel (effient) | 7 days if sole source of platelets |
deferral period for Plavix (clopigrodel) | 14 days if sole source of platelets |
deferral period for pregnancy | 6 weeks post partum |
deferral period for transfusion | 1 year |
deferral period for dura mater graft | indefinite |
deferral period for needle stick | 12 months |
deferral period for lived with or sexual contact with someone with hepatitis B | 12 months |
deferral period for lived with or sexual contact with someone with hepatitis C | IF contact is symptomatic, 12 months; if contact is asymptomatic NONE |
If donor is incarcerated for more than this period of time, he is deferred for 12 months | 72 hours |
deferral period for history of malaria | 3 years after treatment completed |
deferral period for history of living in a malarial area > 5 years | 3 years after moving |
deferral period for history of travel to a malarial area; no symptoms | 12 months |