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Regulation Agencies for blood transfusions
FDA(Food & Drug Administration):
Federal Agency
Required
Publishes the code of federal regulations(CFR)
AABB(Association for the Advancement of Blood & Biotherapies):
Non-governement program
Not required
Ensures compliance with: AABB standard, CFR, CLIA’88
What is the purpose of donor screening?
To protect the donor
To protetct the recipient
How does donor screening protect the donor and the patient from?
Donor:
General health questions are asked( cold, headache, nausea)
Disease history( Previous surgeries, bleeding problems, pregnancy, heart or lung disease)
Recipient:
Disease exposure
Medications
Vaccinations
What information is included on the donor registration?
Date and time of donation
Name
Address
Telephone number
Gender of Donor
Date of Birth
Record of reasons for previous deferrals
Consent for collection, use, and testing
What information must be provided to the donor?
All donors must be given material indicating the signs, symptoms, and high-risk activities associated with HIV and AIDS
Must be notified of abnormal test results; if any
Must be educated on post-donation iron deficiency
What factors are taken into consideration when allowing someone to be a donor?
Medical history
Donation interval (How often they donate)
Major illness/pregnancy
Medications they are on
Vaccinations they have had
Human-derived products injected/ingested
Areas in which they have traveled
If they have been in prison
STDs
What qualifies someone for indefinite deferral?
People who have/ have been administered:
HIV/HTLV 1&2
Hep B;Hep C
Babes, Chagas
vCJD, CJD( Mad cow disease)
Bovine insulin (1980-1996)
Recipient of previous donations has had post transfusion complications
3 year deferral
Asymptomatic after dx/treatment of malaria
After living in a malaria endemic country for 5 years
2 year Deferral
Someone who is on PrEP or PEP injection therapy
12 month deferral
Hepatitis B immune globulin( past exposure)
Incarceration for greater than 72 hours
Human rabies vaccine flowing an animal bite
3 month deferral
Tattoos( Except those done in state-regulated facility w/ sterile needles)
Exposure to blood(transfusion,mucus membrane, or skin penetration)
IV drug use
Prostitution
Multiple sex partners & anal sex
New sex partner & anal sex
Sexual or household contact with person w/ hepatitis
Completion of therapy for syphilis and gonorrhea
Return from travel to a malaria endemic country
PrEP/PEP ORAL therapy
8 week deferral
Smallpox vaccine
Someone who has donated blood in the last 56 days
Double-unit donations within 16 weeks
Platelet donations within 7 days
6 week deferral
Birth of baby
4 weeks deferral
Rubella vaccine-German measles
MMR- measles, mumps, rubella
Varicella-zoster vaccine-chickenpox
Zostavax- live shingles vaccine
3 weeks deferral
Hepatitis B vaccine
2 week deferral
Measles(rubeola) vaccine
Mumps vaccine
Polio (oral) vaccine
Typhoid (oral) vaccine
Yellow fever vaccine
No deferral
Flu Vaccine
Tetanus vaccine
Meningitis vaccine
Shingrix- “dead” shingles vaccine
Covid vaccine
What is the acceptable physical exam criteria
Age-:17 or older(16 with parental consent)
Weight:110lbs
Temperature:less than or equal to 99.5F
Blood pressure: less than 180/100
Pluse: 50-100 beats/min
Hemoglobin: >/= to 12.5g/dL for women; >/= to 13g/dL for men; less than 20 g/dL for everyone
HCT: >/= 38% Female; >/= 39% Male
Venipuncture site: No skin lesions, no evidence of IV drug use
General appearance: In good health, no drug or alcohol abuse suspected
How is the Hgb and Hct determined?
Spectropotometry(Hemocue)-Lysis RBC, oxidizes, measures absorbance
Spun hematocrit-measures the % of RBC in blood
Copper sulfate( blood is dropped in solution; if sinks rapidly-Hgb is good enough for donation)
What is the normal value of the copper sulfate test?
Specific gravity of 1.053= 12.5 g/dL Hgb
Sinks rapidly= Hgb ok for donation
Floats or sinks slowly= Hgb too low for donation
When collecting blood from a donor, what is required?
Donor ID- Unique bar code
Donor medical records
Collection bag
Pilot tube for testing sample against potential recipent
When collecting blood from a donor, what is a part of arm prep?
Disinfection- aseptic technique
Tourniquet: BP cuff; Rubber tourniquet
In blood collection, what does phlebotomy include?
Vein selection- median cubital is 1st choice
Mix blood and anticoagulant during collection( EDTA)
Volume is determined by weight : Most bags are 450mL-500mL
Less than 10% of target volume is labeled “low volume”
Low volume units have plasma discarded
Pilot tubes are filled at the end
What some donor reactions when donating blood?
Fainting
Vomiting
Hyperventilation
Loss of consciousness
Convulsions
What steps should be taken in post donation care?
Make sure the donor is feeling well
Provide post-donation intructions to include:
Report Illnesses such as headache, fever, and nausea
Make sure donor remembers something(DOB, Year, Current president)
Eat and drink
Bandage venipuncture site
Iron supplementation as needed
What test should be done on donor blood?
ABO/Rh
Antibody screen
HBsAg-Test for active Hep B
Anti-HBc-Test for Hep B antibodies
Anti-HCV
Anti-HIV 1&2
Anti-HTLV 1&2
HCV RNA
HBV DNA
HIV-1 RNA
WNV RNA-West Nile Virus
Zika virus RNA
Serological test for Syphilis
Antibody for T. cruzi- Chagas Disease
Can plasma cells from a donor with a positive Antibody screen be used for donation?
No!
What is an autologous donation?
Donation intended for yourself (typical used in elective surgeries)
Eliminates disease transmission
What is a Directed Donation?
Donation specifically for someone else
Comforting for friends and family
Autologous Donation requirements
Must have a physician’s order
No age or weight requirement
Donor Hgb: 11 g/dL
Donor Hct: 33%
Must be labeled “Autologous Use Only”
Test that should be run: ABO & Rh; Disease testing if collection & transfusion facility are different
Directed Donation requirements
Must have a physician order
Must meet all donor requirements
There is a waiting period of several days between collection and distribution