Blood Donor Screening and Regulations

Blood Donor Screening Intro

• Blood transfusions are safer due to established US Food and Drug Administration (FDA) and AABB guidelines
• The Department of Health - National Voluntary Blood Service Program (DOH-NVBSP) regulates Philippines Blood Service Facilities (BSF)

Governing Agencies

• US FDA regulates donor screening and maintains regulations; licenses facilities, blood products, and reagents; makes recommendations for infectious diseases
• AABB (Association for the Advancement of Blood Biotherapies), established in 1947, provides voluntary inspection and accreditation
• CAP (College of American Pathologist) provides voluntary inspection and accreditation, included in hospital clinical lab inspections
• Republic Act No. 7719, the National Blood Services Act of 1994, promotes voluntary blood donation and regulates blood banks
• A voluntary blood donor donates out of own free will, whereas a, walking blood donor is on-call in their community
• House Bill No. 3348 amends Republic Act No. 7719 to promote voluntary blood donation and regulate blood banks

Blood Establishments

• Blood banks/centers recruit and screen donors; collect, process, store, transport and issue blood; and educate on transfusion-transmissible diseases
• Hospital-based blood banks are located in hospitals and perform compatibility testing
• Commercial blood banks exist for profit
• Blood collection units are DOH-authorized to recruit, screen donors, and collect blood

General Principles for Donor Selection

• A donor must give Voluntary Donation and Informed Consent, there must be Privacy and Confidentiality

Whole Blood Donation

• The Frequency of Donation is every 12 weeks
• Males can donate up to 6 standard whole blood donations a year
• Females can donate up to 4 standard whole blood donations a year
• The standard Quantity of Donation is 450 mL ±10% (405 – 495 mL)
• The Age of new donors is 16 –60 years old, and regular donors can donate up to 70 years old, with a medical evaluation
• Lapsed donors over 60 are eligible if evaluated by a medical officer
• The minimum weight is 50 kg
• Hazardous occupations should not be resumed for at least 12 hours after donation
• Post-partum women should wait one year after delivery and 3 months after weaning to donate again

Key Questions to consider

• Can a 450 mL whole blood donation be harmful to the donor?
• Could donating blood transmit a disease to the recipient?

Identity and Information During Registration

• Verify identity with a photographic ID
• Name, address, telephone number, gender, age/DOB, donation type, patient name (if directed), race (for phenotype matching), CMV status
• Allogeneic donors must be 16 years or older, no age restriction for autologous donors

Records and Questionnaires

• Check against previously deferred donor records
• Donor History Questionnaire (DHQ)
  • Ensures donor protection and recipient benefit
  • Standardized
  • Includes self-administered questions, an interview, and yes/no questions
  • Medical history is conducted on the day of donation

Informed Consent

• Required by AABB standards; donors must understand procedure risks and tests performed
• Donors can ask questions; if the donor is a minor, or cannot give informed consent, state law dictates

Types of Deferrals

• Temporary deferral means the donor cannot donate for a limited time
• Indefinite deferral is due to current regulatory requirements; applies to autologous donations; depends on current regulatory requirements
• Permanent deferral means the donor is never eligible to donate for someone else, but eligible to donate autologous blood; results from prior testing

Examples of Reasons for Deferrals

• Temporary: Blood transfusion (12 months), yellow fever vaccine (2 weeks)
• Indefinite: Lived in England for 1 year in 1989
• Permanent: Hepatitis C

Medications and Deferral Periods

• Finasteride/Proscar (prostate enlargement): Defer for 1 month
• Dutasteride/Avodart (prostate enlargement): Defer for 6 months
• Finasteride/Propecia (baldness): Defer for 1 month
• Isotretinoin/Accutane (severe acne): Defer for 1 month
• Acitretin/Soriatane (severe psoriasis): Defer for 3 years
• Etretinate/Tegison (severe psoriasis): Permanent deferral
• Growth Hormone from Human Pituitary Glands (delayed growth): Permanent deferral

Confidential Unit Exclusion

• Donors can indicate if their blood is not suitable for transfusion to others
• Avoids face-to-face admission of risk behaviors

Other Deferrals

• Within 12 months: blood transfusion/transplant, needle stick, tattoos/piercings, sexual contact with high-risk individuals, incarceration
• Temporary deferral: Used clotting factor concentrate (12 months), viral hepatitis at age before 11
• Indefinite deferral: Clinical/lab dx of HIV, unprescribed steroids, HBV NAT testing, Chagas disease, any type of cancer, HBsAg, viral hepatitis at age 11 or later
• Permanent: Received dura mater graft