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TM chap 1-5

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
Created by: jfshikle
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