Donor Screening Flashcards
sets detailed standards that go beyond the FDA’s minimum requirements.
These standards cover all aspects of blood banking, including donor eligibility, collection procedures, testing, blood processing, quality control, and record-keeping.
The American Association of Blood Banks
sets standards for donor screening, blood testing, processing procedures, storage, and transportation.
Facilities must also meet Current Good Manufacturing Practices (CGMP) to be licensed by the FDA.
The United States Food and Drug
Administration
CAP -
JCAHO -
NCLS -
College of the American Pathologists
Joint Commission on the Accreditation of Hospital
Organizations
National Committee for Clinical Laboratory Standards
Two goals of screening
• Protect the health of the potential donor
• Protect the health of the potential recipient
Donor screening
Registration
Health History Interview
Physical Examination
• Documenting information for donor’s identity
• Prevent collection from an unqualified donor
• Contact information for test results or other relevant info
Registration
Donation records include the fallowing:
• Donor’s fullname
• Permanent address/contact infa
• Date of Birth
• Gender
• Date of last donation
donor must be atleast_____ years old:
if the state considers it as minor; parental consent is needed
16
Date of last donation
•______ must elapse between whole blood danations
•_____ must elapse after 2-unit red cell collection
•______ must elapse after infrequent plasmapheresis
•______ must elapse after plasmapheresis, plateletpheresis and leukapheresis
8 weeks
16 weeks
4 weeks
2 days or more
All prospective donors must be given _____describing the donation process and donor eligibility
Information about risks of_____
______must be available for donors not fluent in English or have hearing/vision impaired
educational materials
infectious diseases transmitted by blood transfusion
Communication material
2 Categories:
1.) Questions intended to protect the DONOR
2.) Questions intended to protect the PATIENT/RECIPIENT
Could determine the DEFERRAL STATUS of the donor depending on their answers
Health History Interview
Due to current regulatory requirements that may change in the future
INDEFINITE DEFERRAL
Based on High Risk Behavior or a Positive Test Result
Ex. Hepatitis C
PERMANENT DEFERRAL
No Waiting Time for Temporary Deferral
• Cholera
• Dipthteria
• Hepatitis B (Heptavax)
• Influenza
• Paratyphoid
• Plague
• Polio
• Rabies(Prophylaxis)
• RM spotted fever
• Tetanus
• Typhaid
• Typhus
2 WEEKS - Temporary Deferral
Measles (RUBEOLA) vaccine
Mumps vaccine
Polio (oral vaccine
Typhoid (oral vaccine)
Yellow fever vaccine
4 WEEKS - Temporary Deferral
German measles (RUBELLA) vaccine
Varicella Zoster (Chicken pox) Vaccine
West Nile Virus
6 WEEKS - Temporary Deferral
Conclusion of pregnancy
8 WEEKS - Temporary Deferral
Smallpox immunization
Hepatitis BIG Vaccine, Rabies vaccine
Tattoos or permanent makeup (unless applied by state-regulated facility with sterile needles and ink that is not reused)
Mucous membrane or skin penetration exposure to blood
Sexual contact with an individual at high risk for HIV
Incarceration in a correctional institution for >72 hours
Completion of therapy for syphilis/gonorrhea
Transfusion of blood, components, human tissue, plasma-derived clotting factor concentrates
Human diploid cell-rabies vaccine after animal bite
12 MONTHS - Temporary Deferral
Donors who have had sexual contact with anyone who:
- Has used needles to take drugs NOT prescribed by a physician
- Has taken clotting factor concentrates for a bleeding problem
- Has HIV/AIDS or has had a positive test for HIV
- Women who had sex with man has had sex with other men
12 MONTHS - Temporary Deferral
• History of viral Hepatitis after the eleventh birthday
Indefinite/ permanent
• Confirmed pastive test for hepatitis B surface antigen
• Reactive test to antibodies to hepatitis B core an more then one occasion
• Present ar past clinical or lab evidence of infection with Hep C virus, HTLV or HIV
Indefinite/ permanent
• History of Babesiosis or Chagas Disease
• Family history of CJD
• Recipient of dura mater or human PGH
• Risk af vCJD
Indefinite/ permanent
• Use of needle to administer nonprescription drugs
Indefinite/ permanent