Blood Collection Regulations and Standards: Ensuring Safe Blood Supply

1. Unit 1 Part 1 Blood Collection MLAB 2431 Immunohematology

2. Standards, Regulations, Governing Bodies • Regulations are in place by the US government to ensure the safety of the blood supply for the nation. • Includes the following agencies: • FDA – Food and Drug Administration • Inspect blood banks and blood centers • AABB – American Association of Blood Banks • CAP – College of American Pathologists • JCAHO – Joint Commission on Accreditation of Healthcare Organizations • CLSI – Clinical Laboratory Standards Institute

3. Blood Bank vs. Blood Center • Blood bank (transfusion service) performs compatibility testing and prepares components for transfusion • Blood center is the donation center, where donors are screened, units are drawn, testing on donor blood, and distribution of blood and blood components to the hospital blood banks.

4. Donor Screening • All blood comes from volunteer donors • Two goals for screening donors • Protect the health of the potential donor • Protect the health of the potential recipient • Screeners are training to ask appropriate questions, observe and interpret the responses • Three components to screening • Registration • Health history interview • Limited physical examination

5. Donor Registration • Donor signs in (usually makes an appointment) • Written materials provided to the donor • Explains high risk activities –may lead to donor ineligibility • Donor must be informed and give consent that their blood will be used for others • First time donors must provide proof of identification including SS#, DL#, DOB, and address • Repeat donors need to show DL

6. Donor Registration • Donor will provide information for donation in a group name or for an individual • Donor must be informed of • HIV high risk activities • Possible donor reactions (post-donation) • All tests that are performed • Post phlebotomy instructions

7. How often can I donate? • Frequency of donation • Whole blood or red blood cell donation – every 8 weeks • Two unit red cell donation – every 16 weeks • Male – must be at least 17 years of age; 5’1” tall, and at least 130 pounds • Female – must be at least 19 years of age; 5’4” tall, and at least 150 pounds • Platelet apheresis – up to 24 times/year • Plasmapheresis – once every 4 weeks

8. Medical History • Critical for the blood supply to stay safe • Questions may be intimate in nature, but are critical for assessing HIV or HBV risk • If donor has been deferred in past, why? • Medications, infections, travel – all may be reasons for deferral • Will be discussed in laboratory exercise one

9. Permanent Deferrals • Deferrals where a donor may never donate • Anyone who has ever used intravenous drugs (illegal IV drugs) • Anyone with a positive test for HIV (AIDS virus) • Men and women who have engaged in sex for money or drugs • Anyone who has had hepatitis since his or her eleventh birthday • Anyone who has had babesiosis or Chagas disease • Anyone who has taken Tegison for psoriasis • Anyone who has risk factors for Crueutzfeldt-Jakob disease (CJD) or vCJD or who has a blood relative with CJD

10. Permanent Deferrals • Deferrals where a donor may never donate • Anyone who spent three months or more in the United Kingdom (UK) from 1980 through 1996 • Anyone who received a blood transfusion in the UK or France from 1980 to the present • Anyone who has spent five years in Europe from 1980 to the present. • Anyone with diabetes since 1980, ever used bovine (beef) insulin made from cattle from the UK • Hepatitis B and/or C • Received a dura mater graft • Most cancers • Anyone who has ever had Ebola

11. Permanent Deferrals • Deferrals where a donor may never donate • Donors who have lived in certain countries in Africa since 1977 (see list below) are indefinitely deferred. • Donors may have been exposed to rare strains of HIV that are not consistently detected by all current test methods.

12. 12-month Deferrals • Donor has been in contact with persons who, in the past or present, have used needles to take drugs, steroids or anything not prescribed by their physician • Heart issues* • Transfusion of blood or blood products • Sexual partner of someone in a high risk group • Tattoos • Ear/body piercing-persons who have had ear or body piercing during the previous 12 months** • Accidental exposure to blood or body fluid • Rabies vaccine after animal bite

13. 12-month Deferrals • Had sexually transmitted disease • Travel to Iraq • Travel to an area where malaria is prevalent • Donor incarcerated in a facility for more than 72 consecutive hours • MSM • Skin graft or tissue transplant (including corneas) • Donor with sexual contact with any person who has received clotting factor concentrates • Hepatitis exposure • Hepatitis B immune globulin shot

14. Temporary Deferrals • Pregnancy – six weeks after delivery • Medications – see list in laboratory exercise one • West Nile virus – 120 day wait after symptom free • Zika virus – 120 day wait after diagnosis

15. Temporary Deferrals • Immunizations • Two weeks – Red measles (rubeola), mumps, oral polio, oral typhoid, or the yellow fever vaccine • Four weeks – German measles (rubella), chicken pox (varicella zoster), MMR, Zostavax – the live shingle vaccine • Smallpox – wait 8 weeks if no complications (see laboratory exercise one for additional information) • Hepatitis B vaccine – wait 21 days • Unlicensed vaccines – wait one year

16. Additional Deferral Info • No deferral, if symptom-free • Anthrax, cholera, diphtheria, influenza, • Lyme disease, paratyphoid • Polio injection, routine rabies, Tdap, tetanus or HPV vaccine • Malaria – three year wait after treatment • Three year wait after living more than 5 years in a country endemic for malaria

17. Remember… • Permanent deferral • any member of high risk group such as: HIV/HBV/HCV pos, drugs/sex for money, cancer, serious illness or disease, CJD, Chagas disease, Babesiosis • 12 month deferral • sex with any high risk group, any blood exposure, recipient of blood/blood products, STD, jail/prison, rabies vaccine after exposure, HBIG, malaria • Have to memorize: medications and vaccinations

18. Physical Examination • Personnel know how to evaluate general appearance • Weight – 110 1bs national, 123 lbs. Austin – eff. Jan 2010 • Temperature 37.5 C OR 99.5F • Blood pressure • Systolic </= to 180 mm Hg • Diastolic </= 100 mm Hg • Hemoglobin and Hematocrit • Allogenic 12.5 g/dL or 38% • Autologous 11.0 g/dL or 33%

19. Self Exclusion • Two stickers • “Yes, use my blood” • “No, do not use my blood” • After interview the donor will place the appropriate bar coded label on the donation record • If “no” selected the unit is collected, fully tested, but not used for transfusion • Allows donors who know they are at risk to “save face” if pressured to donate by friends and family

20. Donor Categories • “Allogeneic”, “homologous” and “random donor” terms used for blood donated by individuals for anyone’s use • Autologous – donate blood for your own use only • Recipient Specific Directed donation – donor called in because blood/blood product is needed for a specific patient • Directed Donor – patient selects their own donors • Therapeutic bleeding – blood removed for medical purposes such as in polycythemia vera. NOT used for transfusion.

21. References • https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cber/