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