1. Blood Collection MLAB 2431 Immunohematology
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
FDA includes CBER (Center for Biologics Evaluation and Research) which regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals from blood and blood components. These include clotting factors and Rh immune globulin. CBER also regulated the cell separation devices, blood collection containers and HIV screening tests to ensure safety of the blood supply.
In addition to strengthening these safeguards, FDA has significantly increased its oversight of the blood industry:
FDA inspects all blood facilities at least every two years, and "problem" facilities are inspected more often.
Blood establishments are now held to quality standards comparable to those expected of pharmaceutical manufacturers.
AABB is dedicated to making transfusion medicine and cellular therapies safe worldwide. It is the leader in standards development, and accreditation.
The College of American Pathologists (CAP), the leading organization of board-certified pathologists, serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. The CAP team members will inspect the blood banks along with the rest of the laboratory every two years.
The Joint Commission is a United States-based nonprofit tax-exempt organization[ that accredits more than 21,000 US health care organizations and programs. JCAHO is committed to continuously improve the safety and quality of patient care. All member health care organizations are subject to a three-year accreditation cycle, and laboratories are surveyed every two years.

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
Donors may be giving blood for other reason such as a directed donation, which we will discuss later.

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 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 (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
*Heart attack or heart surgery including pacemaker or implanted defibrillator
Tattoos-NOT performed by a state regulated entity with sterile needles and non-reused ink
**Ear/body piercing-persons who have had ear or body piercing during the previous 12 months; acceptable if performed under sterile conditions, with a single use device, must be healed without signs of infection.

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
Travel to a malaria area-donors who have been to an area where malaria is considered endemic will be deferred for 12 months after departure from that area regardless of whether they took anti-malaria prophylaxis.
*Men having sex with men – eligible to donate if they have not had sex with another man in 12 months*
This has changed in the last three years

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 12 month 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%
These are the guidelines established by the We Are Blood blood center here in Austin. The B/P is not a requirement by the FDA; therefore, the medical director of the facility establishes the protocol for this component of the physical examination.

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
This type of practice is not required; however, some blood banks may use this practice for donors as stated to “save face”.

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.
Sample donor labels are presented here for an autologous donor and a directed donation. When these donations are performed at the local blood center, the blood center labels them as appropriate before they are transported to the hospital for patient use.
Safest is autologous, blood is your own, no risk of disease acquisition
Most dangerous is Directed Donor, you select a donor who may, unknown to you, be in a high risk category but feels obligated to follow through and donate

21. References
alproductsandtobacco/cber/