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

# 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] |