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SOPs/Donor-Services/SOP-BB-001-Donor-Screening.md

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+# Standard Operating Procedure: Blood Donor Screening
+
+| Document ID | SOP-BB-001 |
+|-------------|-------------|
+| Title | Blood Donor Screening and Eligibility |
+| Revision | 1.0 |
+| Effective Date | [DATE] |
+| Author | [AUTHOR] |
+| Approved By | [APPROVER] |
+| Department | Donor Services |
+
+---
+
+## 1. Purpose
+
+To establish standardized procedures for screening potential blood donors to ensure donor safety and the safety of the blood supply in accordance with FDA, AABB, and state regulations.
+
+## 2. Scope
+
+This procedure applies to:
+- Whole blood donations
+- Apheresis donations (platelets, plasma, red cells)
+- Autologous donations
+- Directed donations
+
+## 3. Responsibilities
+
+### 3.1 Donor Registration Staff
+- Verify donor identity
+- Complete registration process
+- Explain donor education materials
+
+### 3.2 Donor Screening Personnel
+- Conduct health history interview
+- Perform mini-physical examination
+- Determine donor eligibility
+
+### 3.3 Medical Director
+- Establish deferral criteria
+- Review complex eligibility questions
+- Authorize exceptions when appropriate
+
+## 4. Definitions
+
+| Term | Definition |
+|------|------------|
+| Allogeneic | Donation intended for another person |
+| Autologous | Donation for one's own use |
+| Deferral | Temporary or permanent exclusion from donation |
+| DHQ | Donor History Questionnaire |
+
+## 5. Equipment and Materials
+
+- FDA-approved Donor History Questionnaire
+- Blood pressure monitor (calibrated)
+- Thermometer
+- Hemoglobin/hematocrit testing device
+- Venipuncture supplies for sample collection
+- Donor education materials
+- Deferral registry access
+
+## 6. Procedure
+
+### 6.1 Donor Registration
+
+1. **Identity Verification**
+   - Require valid government-issued photo ID
+   - Verify name, date of birth
+   - Check against deferral registry
+   - Record donor identification number
+
+2. **Educational Materials**
+   - Provide donor education materials
+   - Ensure donor has read and understood:
+     - Risk behaviors
+     - Signs/symptoms requiring self-deferral
+     - Post-donation instructions
+   - Document acknowledgment
+
+### 6.2 Health History Interview
+
+1. **Questionnaire Administration**
+   - Use current FDA-approved DHQ version
+   - Conduct in private setting
+   - Allow donor to self-complete or assist as needed
+   - Review all responses with donor
+
+2. **Key Assessment Areas**
+
+   **General Health**
+   - [ ] Feeling healthy today
+   - [ ] Weight ≥110 lbs (50 kg)
+   - [ ] Age requirements met
+   - [ ] No recent illness/infection
+
+   **Medical History**
+   - [ ] Medications (prescription and OTC)
+   - [ ] Chronic conditions
+   - [ ] Recent surgeries/procedures
+   - [ ] Cancer history
+   - [ ] Heart/lung conditions
+   - [ ] Bleeding disorders
+
+   **Infectious Disease Risk**
+   - [ ] Fever in past 3 days
+   - [ ] Travel history (endemic areas)
+   - [ ] Vaccinations (recent)
+   - [ ] Tattoos/piercings (recent)
+   - [ ] Contact with infectious diseases
+
+   **Risk Behaviors**
+   - [ ] Sexual history per FDA guidance
+   - [ ] IV drug use
+   - [ ] Incarceration history
+
+3. **Interview Documentation**
+   - Record date and time
+   - Interviewer signature
+   - Donor signature affirming truthfulness
+
+### 6.3 Mini-Physical Examination
+
+| Parameter | Acceptable Range | Action if Outside Range |
+|-----------|------------------|------------------------|
+| Temperature | ≤99.5°F (37.5°C) | Defer |
+| Blood Pressure | Systolic 90-180 mmHg, Diastolic 50-100 mmHg | Defer if outside |
+| Pulse | 50-100 bpm, regular | Defer if irregular or outside range |
+| Hemoglobin | ≥12.5 g/dL (female), ≥13.0 g/dL (male) | Defer |
+| Weight | ≥110 lbs | Defer |
+| Arms | Free of lesions, track marks | Defer if concerning |
+
+1. **Temperature**
+   - Measure oral temperature
+   - Wait 10 min if donor consumed hot/cold beverages
+
+2. **Blood Pressure and Pulse**
+   - Donor seated 2-3 minutes before measurement
+   - Use appropriate cuff size
+   - Record all values
+
+3. **Hemoglobin Testing**
+   - Perform fingerstick using approved device
+   - Follow manufacturer instructions
+   - Record result and device lot number
+
+4. **Arm Inspection**
+   - Examine both arms
+   - Check for:
+     - Skin lesions or infections
+     - Track marks
+     - Suitable veins
+
+### 6.4 Eligibility Determination
+
+1. **Eligible to Donate**
+   - All criteria met
+   - No deferral conditions identified
+   - Document approval
+   - Proceed to collection
+
+2. **Temporary Deferral**
+   - Document specific reason
+   - Calculate reinstatement date
+   - Provide deferral notice to donor
+   - Record in deferral registry
+   - Common reasons:
+     | Reason | Deferral Period |
+     |--------|-----------------|
+     | Low hemoglobin | 56 days minimum |
+     | Tattoo/piercing | Per state/facility policy |
+     | Recent vaccination | Varies by vaccine |
+     | Travel to endemic areas | Varies by location |
+     | Medication | Varies by drug |
+
+3. **Permanent Deferral**
+   - Document reason
+   - Notify donor in writing
+   - Record in deferral registry
+   - Offer post-donation counseling if appropriate
+
+### 6.5 Confidential Unit Exclusion
+
+- Offer confidential opportunity to self-exclude
+- Provide private means (ballot, sticker, phone call)
+- Document without identifying donor choice
+- Units designated for discard are processed but not used
+
+## 7. Special Situations
+
+### 7.1 Therapeutic Phlebotomy
+- Prescription required
+- Separate eligibility criteria may apply
+- Label units appropriately
+
+### 7.2 Autologous Donation
+- Less stringent hemoglobin requirements
+- Must meet basic safety criteria
+- Physician order required
+
+### 7.3 Directed Donation
+- Same eligibility criteria as allogeneic
+- Document relationship to recipient
+
+## 8. Documentation
+
+- FRM-BB-001 Donor Registration Form
+- Donor History Questionnaire (completed)
+- FRM-BB-002 Mini-Physical Results
+- Deferral notification (if applicable)
+- Consent for donation
+
+## 9. Quality Control
+
+| Activity | Frequency |
+|----------|-----------|
+| Hemoglobin device QC | Per manufacturer |
+| BP monitor calibration | Annually |
+| DHQ version check | Monthly |
+| Staff competency | Annually |
+
+## 10. References
+
+- FDA Guidance for Industry: Blood Establishment Registration
+- AABB Standards for Blood Banks and Transfusion Services
+- 21 CFR Part 606 - Current Good Manufacturing Practice for Blood
+- State regulations for blood collection
+
+---
+
+## Revision History
+
+| Rev | Date | Description | Author |
+|-----|------|-------------|--------|
+| 1.0 | [DATE] | Initial release | [AUTHOR] |