Qualification

This section discusses Blood Product Donors by looking at donor Qualification. Think of this as the essential first step in guaranteeing the safety and effectiveness of blood transfusions. It’s a carefully designed process with two primary goals: protecting the health of the potential recipient by ensuring the donated blood is safe, and safeguarding the well-being of the donor throughout the donation process. This screening is guided by strict regulations from the FDA and standards set by organizations like AABB, involving a detailed health history review and a mini-physical exam before anyone can donate. The goal here is twofold:

  1. Protect the recipient We need to make sure the blood donated is safe and won’t transmit diseases or cause harm
  2. Protect the donor We need to ensure the donation process itself is safe for the person giving blood and won’t negatively impact their health

Eligibility is determined through a multi-step process:

Registration & Identification

  • This seems basic, but it’s vital! We need to positively identify the donor and link them to their donation history and the collected unit
  • We collect demographic information and check if they’ve donated before or have any existing deferrals. Photo ID is usually required

Educational Materials

  • Before the nitty-gritty questions, donors receive information explaining the donation process, potential risks (like bruising or fainting), eligibility requirements, and very importantly, information about diseases transmitted by blood, like HIV/AIDS and hepatitis
  • This material emphasizes the importance of honesty and provides donors with an opportunity to self-defer if they realize they might be at risk before going through the whole screening

Donor Health History Questionnaire (DHQ)

  • This is the core of the screening! It’s a standardized set of questions designed to identify potential risks. While the exact wording might vary slightly between centers, the intent and scope are consistent. Key areas covered include:
    • General Health: Are you feeling healthy and well today? Any colds, flu, sore throats?
    • Medical Conditions: History of cancer, heart or lung disease, bleeding disorders, unexplained weight loss, certain infections (HIV, hepatitis B/C, syphilis, babesiosis, Chagas disease, etc.)
    • Medications: Use of certain drugs can be grounds for deferral, either because the drug itself could harm a recipient (like Accutane, Propecia, Soriatane) or because the underlying condition it treats makes donation unsafe (like anticoagulants, bovine insulin). Antibiotic use might indicate an active infection
    • Travel History: Recent travel to areas endemic for certain diseases, especially malaria, vCJD (variant Creutzfeldt-Jakob disease - associated with travel/residence in parts of Europe), Zika, or Ebola, may result in temporary or indefinite deferral
    • Risk Behaviors Associated with Bloodborne Pathogens: Questions about intravenous drug use (even once!), history of payment for sex, specific sexual contact scenarios (e.g., men who have sex with men - MSM guidelines have evolved recently based on individual risk assessment rather than blanket deferral in some regions, but specific questions remain), contact with individuals known to have HIV or hepatitis
    • Vaccinations: Waiting periods apply after receiving certain live-attenuated vaccines (e.g., MMR, chickenpox). No deferral for most inactivated or mRNA vaccines (like flu shots or most COVID-19 vaccines)
    • Previous Transfusions/Donations: Have they received blood, components, or grafts? When was their last donation? Any issues with previous donations?
    • Surgery, Tattoos, Piercings: Recent procedures might require a waiting period due to potential infection risk

Physical Examination (“Mini-Physical”)

  • This is a quick check of the donor’s vital signs and physical state at the time of donation
    • Hemoglobin/Hematocrit: Must meet a minimum level to ensure the donor doesn’t become anemic from donating. (Commonly: Allogeneic Hgb ≥ 12.5 g/dL for females, ≥ 13.0 g/dL for males)
    • Blood Pressure: Must be within an acceptable range (e.g., Systolic ≤ 180 mmHg, Diastolic ≤ 100 mmHg). High BP might indicate risk to the donor
    • Pulse: Needs to be regular and within range (e.g., 50-100 beats per minute). Very high or low rates might need further evaluation
    • Temperature: Must be normal (e.g., ≤ 37.5°C or 99.5°F) to rule out fever/active infection
    • Weight: Minimum weight required (usually ≥ 110 lbs or 50 kg) to ensure a safe volume of blood can be drawn relative to total blood volume
    • Arm Check: Examination of the antecubital area (where the needle goes) to check for rashes, lesions, or signs of IV drug use (“track marks”)

Deferrals

  • If a donor doesn’t meet the criteria at any stage, they are deferred. Deferrals can be:
    • Temporary: Requires waiting a specific period (e.g., after taking certain medications, travel to a malaria zone, recent tattoo, low hemoglobin)
    • Indefinite: No set end date, often due to high-risk factors (e.g., history of IV drug use, certain medical conditions like leukemia). The donor might become eligible later if criteria change
    • Permanent: The donor will never be eligible (e.g., confirmed positive test for HIV, viral hepatitis B/C after certain dates, history of Chagas disease, vCJD risk)

Key Takeaway

Donor qualification is a rigorous but essential process. It relies heavily on donor honesty and adherence to established regulatory standards. Every step is designed to maximize the safety of the blood product for the eventual recipient while also ensuring the well-being of the generous individual donating

Key Terms

  • Allogeneic Donation: Blood donated by an individual for transfusion into another person (the general blood supply). This is the most common type of donation and has strict qualification criteria
  • Autologous Donation: Blood donated by an individual specifically for their own future use, typically before scheduled surgery. Qualification criteria might be slightly modified by the medical director, but basic safety checks still apply
  • Donor Health History Questionnaire (DHQ): A standardized set of questions required by regulatory agencies (like the FDA) used to screen potential donors for risk factors related to their health, medications, travel, and behaviors that could affect donation safety for both donor and recipient
  • Deferral: The decision to not accept an individual for blood donation based on failure to meet eligibility criteria. Deferrals protect both the donor and potential recipients
  • Temporary Deferral: A deferral that prevents donation for a specific, limited period. Examples include recent travel to a malaria-endemic area, taking certain medications, or having a low hemoglobin level on the day of donation
  • Indefinite Deferral: A deferral without a defined end date, often due to higher-risk factors (e.g., certain past behaviors or medical conditions). The donor might become eligible in the future if screening criteria change
  • Permanent Deferral: A deferral indicating the donor will never be eligible to donate blood again according to current regulations (e.g., confirmed positive test for HIV, Hepatitis C, or history of IV drug use)
  • Informed Consent: The process where a potential donor, having received and understood information about the donation process, associated risks, required testing, and potential uses of the blood, formally agrees to donate
  • AABB (Association for the Advancement of Blood & Biotherapies): A key professional organization that sets standards of practice and provides accreditation for blood banks and transfusion services, often influencing or exceeding regulatory requirements for donor qualification
  • Hemoglobin (Hgb) / Hematocrit (Hct) Check: A mandatory part of the donor mini-physical exam to measure the oxygen-carrying capacity of the blood. Donors must meet a minimum level (e.g., Hgb ≥ 12.5 g/dL for females, ≥ 13.0 g/dL for males for allogeneic donation) to ensure the donation won’t make them anemic