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

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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

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Revision History

Rev	Date	Description	Author
1.0	[DATE]	Initial release	[AUTHOR]