DONOR

SELECTION
 OBJECTIVES
1. Identify the organizations that regulate or accredit the immunohematology laboratory.
2. State the acceptable levels for the following tests in allogeneic and autologous donation:
• Weight
• Temperature
• Hemoglobin
• Hematocrit
3. Differentiate between acceptable donation, and temporary, indefinite, and
permanent deferral given various medical conditions.
4. Differentiate among the four different types of autologous donations.
5. Describe the procedure for a whole blood donation, including arm
preparation, blood collection, and postphlebotomy care instructions for the donor.
 OBJECTIVES
6. Differentiate among mild, moderate, and severe reactions, and state recommended treatments
for each.
7. List the tests required for allogeneic, autologous, and apheresis donation.
8. State the acceptable interval of donation for allogeneic, autologous, and apheresis donors.
9. Discuss record-keeping procedures for allogeneic, autologous, and apheresis donors.
10. Compare and contrast donor reentry protocols for donors who previously tested
positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV),
hepatitis B virus (HBV).
11. Describe a hematoma and how it is treated.
12. Discuss how a human is infected with West Nile virus (WNV) and how
donors are tested.
 OBJECTIVES
13. Compare and contrast Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease
(vCJD) regarding age of onset and immunohistochemistry.
14. Define prion.
15. Identify endemic countries for malaria and donor regulations affecting U.S. military
personnel.
16. State deferral criteria for Babesia, Zika, and Ebola.
17. List donor screening and confirmation tests for human T-cell lymphotrophic
virus type I/II (HTLV-I/II).
18. State a contraindication for autologous donation.
19. State serologic tests required for directed donations.
 INTRODUCTION
• In the last 5 years, the selection of potential
blood donors has become more rigorous

• The transfusion of blood to a patient in need

is safer than it has ever been.

• Safety and therapeutic benefits are

dependent on guidelines established by the
U.S. FDA and AABB
GOVERNING AGENCIES
o U.S. Food and Drug Administration
o AABB
o College of American Pathologists
 GOVERNING AGENCIES
• Guidelines and regulations for donor selection
and serologic testing are written by the FDA
and AABB.

• Their institutional goals and national donation

guidelines provide an effective framework of
processes.

• CAP conducts inspections of all clinical

laboratory departments.
 U.S. Food and Drug Administration
(Regulating Agency)
• Code of Federal Regulations (CFR), Title 211. parts 2, 600-799.
• In the early 1990s, FDA began to treat blood establishments the
same as any drug manufacturer.
• establishes and maintains the regulations and inspects blood
collection and processing centers
 U.S. Food and Drug Administration
(Regulating Agency)
• FDA is also responsible for licensing the collection and processing
facilities, the blood products and derivatives, and the reagents
used in the processing and testing of those products.
• provides recommendations and requirements regarding
infectious diseases as well as potential emerging diseases.
 American Association of Blood Banks
(1947)
• It is an international association of blood centers, transfusion and
transplantation services.
• It provides a voluntary inspection and accreditation program for its
member institutions that meet the requirements of the CMS and CLIA.
• The mission of the AABB is to establish and provide the highest
standard of care for patients and donors in all aspects of
transfusion medicine.
 American Association of Blood Banks
(1947)
• The AABB has published books on transfusion medicine
throughout its existence that are vital to donor screening
procedures
• AABB Standards for Blood Banks and Transfusion Services and
the AABB Technical Manual
 College of American Pathologists
• Also provides a voluntary inspection and accreditation program for its
member institutions.
• Since most transfusion services are part of the clinical laboratory
departments in a hospital, those services are included in a CAP
inspection.
• As with the AABB inspections, CAP inspections are approved
by CMS and meet the CLIA requirements.
DONOR SELECTION
o Registration
o Medical History Questionnaire
o Medical History Questions
o The Physical Examination
o Informed Consent
o Autologous Donation
o Directed Donation
o Apheresis Donation
 DONOR SELECTION
• medical history requirements for the donor
• the (partial) physical examination
• serologic testing of the donor blood

1) Will a donation of approximately 450 mL of whole blood

be harmful to the donor?
1) Could blood drawn from this donor at this time
potentially transmit a disease to the recipient?
Registration
List of information used by the collection facility in the registration process and is kept on
record by use of a single record form or electronically:

ü Name (first, last, MI)

ü Date and time of donation
ü Address
ü Telephone
ü Gender
ü Age or date of birth
Registration
List of information used by the collection facility in the registration process and is kept on
record by use of a single record form or electronically:

ü Consent to donate
- procedure and potential risks
- educational materials
ü Additional information
- name of the patient for whom the blood is intended
- Race of the donor for matching specific phenotypes
- Cytomegalovirus (CMV) status
Pg. 283
Medical History Questionnaire
• Standardized medical history questionnaire
- donor history questionnaire (DHQ)
- developed by a task force that included representatives from:
ü AABB
ü FDA
ü blood and plasma industry
- designed to be self-administered by the donor but, if
preferred, may be administered by a trained donor
historian
Medical History Questionnaire
• Self-administered questionnaires
- must be reviewed by trained personnel before completing the screening
process and prior to collecting blood
- interviewer should be familiar with the questions
- interview should be conducted in a secluded area of the
blood center or donor site
- designed so that a simple yes or no can be answered
and elaborated, if indicated
Medical History Questionnaire
• Three types of deferrals:

1. Temporary - donor cannot donate for a specified time period,

such as 2 weeks from receipt of the polio vaccine
2. Indefinite - donor is prohibited from donating blood to
another person for an unspecified period of time

3. Permanent - donor may never donate blood to another person

Figure 13–1. Revised donor history questionnaire. Pg. 284-285
Medical History Questions
o Are you feeling healthy and well today?

o Are you currently taking an antibiotic or taking any other medications for an
infection?

o Are you taking or have you ever taken any medications on the Medication
Deferral List?

o Have you read the educational materials?

o In the past 48 hours, have you taken aspirin or anything with aspirin in it?
Pg. 286
Pg. 287

Figure 13–2. Medication deferral list. (U.S. Food and Drug

Administration, “Guidance for industry: Implementation of
acceptable full-length Donor History Questionnaire
and accompanying materials for use in screening donors of
blood and blood components,” October 2006.)
Medical History Questions
o In the past 6 weeks, have you been pregnant or are you pregnant now?
• Female donors should be temporarily deferred for 6 weeks following termination of pregnancy.
• first trimester or second trimester abortion or miscarriage is not cause for deferral.
• 12-month deferral would apply if the woman received a transfusion during her pregnancy.
o In the past 6 weeks, have you been pregnant or are you pregnant now?
• time interval b/n allogeneic whole blood donations is 8 weeks or 56 days
• prospective donor participated in an apheresis donation at least 48 hours must pass before donating
whole blood.
• apheresis donor may only donate twice in a period of 7 days and only once in 7 days for a double or
triple apheresis donation
• infrequent plasma apheresis requires a 4-week deferral
Medical History Questions
o In the past 8 weeks, have you had any vaccinations or other shots? Have you
had contact with someone who had a smallpox vaccination?
• live attenuated or bacterial vaccine: 2-week deferral
• donor received a live attenuated vaccine for German measles or chickenpox: 4 week deferral
• no deferral for toxoids or killed or synthetic viral, bacterial, or rickettsial vaccines if the donor is
symptom-free and afebrile
• smallpox vaccination deferral for 14 to 21 days or until the scab has fallen off
• FDA defines close contact as exposure to the vaccination site or bandages, clothing, towels, or
bedding that have been in contact with the vaccination site
• additional question:“If you have had the smallpox vaccine, has the scab fallen off by itself?”
 Medical History Questions
o In the past 12 months have you had a blood transfusion; a transplant such as
organ, tissue, or bone marrow; or a graft such as bone or skin?
• received a transfusion of blood or its components or other human tissues should be
deferred for 12 months from the time of receiving the blood product or graft

o In the past 12 months have you come in contact with someone else’s blood or
had an accidental needle-stick injury? Had a tattoo? Had an ear or body piercing?
• deferral is 12 months
• Exposure is assumed if the blood came in contact with an open wound or any nonintact
skin or mucous membranes (e.g., nose, mouth, eyes)
• Skin-penetrating injuries: tattoos, permanent makeup, and ear and body piercings
Medical History Questions
o In the past 12 months, have you had sexual contact with anyone who has HIV/AIDS or has had a
positive test for HIV/AIDS?
• 12 months deferral

o In the past 12 months, have you had sexual contact with a prostitute or
anyone else who takes money or drugs or other payment for sex?
• 12 months deferral

o In the past 12 months, have you had sex with anyone who has ever used a needle to
take drugs or steroids or anything not prescribed by their doctor? In the past 12
months, have you ever had sex with anyone who has hemophilia or has used clotting
factor concentrates?
• past or present IV drug user: deferred for 12 months
• person with hemophilia/related blood disorder who has received factor concentrates: deferred for 12
months
Medical History Questions
o Male donors: Have you had sexual contact with another male in the past 12
months?
• MSM: males who have had sex with another male
• 1985: FDA began instituting an indefinite deferral for MSM since 1977, even if the sexual contact only
happened once
• Department of Health and Human Services initiated public discussion toward a revision of policy
• Multiple factors were involved, including: ü operational assessment,
ü DHQ studies
ü Retrovirus Epidemiology Donor
ü Study II (REDS II)
ü REDS III, and
ü supportive data from other countries
Medical History Questions
o Female donors: Have you had sexual contact with a male who has ever had
sexual contact with another male?
• Women who have had sex with an MSM in the past 12 months should be deferred for 12 months

o Female donors: Have you had sexual contact with a male who has ever had
sexual contact with another male?

o In the past 12 months, have you been treated for syphilis or gonorrhea?

o Have you been in juvenile detention, lockup, or prison for more than 72
hours?
Medical History Questions
o In the past 3 years, have you been outside of the United States or Canada?
• malaria
• Creutzfeldt-Jakob disease and variant Creutzfeldt-Jakob disease (CJD or vCJD)
• leishmaniasis

v Malaria
• deferred for 3 years after becoming asymptomatic
• lived longer than 5 years in malaria-endemic countries and who have been a resident of
nonendemic countries for less than 3 consecutive years are deferred for 3 years.
• If a prior resident of a malaria-endemic country returns to a malaria-endemic area after residence
for 3 years consecutively in a nonendemic country, that donor is deferred for 1 year
Pg. 289
 v CJD and vCJD: Creutzfeldt-Jakob disease and variant Creutzfeldt-Jakob disease
• members of a group of neurological disorders known as the transmissible spongiform encephalopathies
(TSE) or prion diseases, affect sheep, cows, and humans
• results in progressive dementia and spongiform alterations in the brain and is rapidly fatal
• transmitted by corneal transplants, human dura mater grafts, pituitary derived human growth hormone,
and neurosurgical instruments
• eating beef contaminated with prions, abnormal proteins found in the brain tissue of diseased cattle,
which led to the term “mad cow disease.”
• humans ingest contaminated beef from a diseased cow they can develop vCJD
• As of 2015, 228 patients have been diagnosed with clinical vCJD.
• These cases involved the following countries: United Kingdom, United States, Canada, France, Austria,
Belgium, Czech Republic, Denmark, Finland, Germany, Greece, Ireland, Italy, Liechtenstein,
Luxembourg, Netherlands, Poland, Portugal, Spain, Switzerland, Sweden, Israel, and Japan
Pg. 290
v Leishmaniasis:

• Leishmania spp - intracellular protozoan parasites that cause leishmaniasis

• are endemic in tropical and subtropical areas in the Middle East, Mediterranean coast, Africa, Central
and South America, and Asia
• transmitted to humans by the sand fly (Phlebotomus) infected with Leishmania
• Clinical manifestations range from cutaneous lesions to visceral infections that may be fatal
• There have been 15 cases of transfusion-transmitted leishmaniasis reported in the literature,
primarily involving Leishmania donovani
• 2003, with the deployment of military and National Guard troops in Iraq, a 12-month deferral from
the date of departure from the area was instituted for any military personnel stationed in Iraq and
any civilian and contract personnel who have visited the country.
Medical History Questions
o Had a positive test for HIV/AIDS virus?

o Used needles to take drugs, steroids, or anything not prescribed by your doctor?

o Used clotting factor concentrates?

o Had hepatitis?

o Received a dura mater (or brain covering) graft?

Medical History Questions
o Had Chagas disease? Had babesiosis?
• American trypanosomiasis, caused by the protozoan parasite Trypanosoma cruzi
• vector responsible for transmitting the parasite
• hematophagous bug belonging to the family Reduvidae
• transmitted congenitally by breastfeeding, organ transplants, or blood transfusion
• Babesia microti utilizes the vector Ixodes scapularis
• penetrates the erythrocyte where the trophozoite multiplies; upon lysis, the RBC
merozoites are released into the blood where they are free to infect other RBCs.
• symptoms: malaise, fatigue, anorexia, arthralgia, nausea, vomiting, abdominal pain, and
fever reaching temperatures of 40°C
Medical History Questions
o Had any type of cancer, including leukemia?

o Had any problems with your heart or lungs?

o Had a bleeding condition or a blood disease?

o Been in Africa?

o Had sexual contact with anyone who was born or has lived in Africa?

o Have any of your relatives had Creutzfeldt-Jakob disease (CJD)?

o Have you ever received a xenotransplantation?

Pg. 291
Physical Examination
• General appearance:
- excessive anxiety
- drug or alcohol influence
- nervousness

• Weight:
- weight at least 110 lbs
- maximum of 10.5 mL of blood/kg of donor weight for whole blood
- collection, inclusive of pilot tubes for testing
- donor weighs less than 100 pounds, amount of blood collected must be
- proportionately reduced as well as that of the anticoagulant
Physical Examination
• Temperature:
- less than or equal to 37.5°C or 99.5°F
• Hemoglobin:
- greater than or equal to 12.5 g/dL
- hematocrit level greater than or equal to 38%
- women in allogeneic donations and >/= 13.0 g/dL (hemoglobin) and 39%
(hematocrit) for men
- autologous donation hemoglobin and hematocrit level: >/= 11.0 g/dL and 33%
Physical Examination
• Skin lesions:
- donor’s arms should be inspected for skin lesions
- skin disorders that are not cause for deferral
include poison ivy and other rashes; should not
be present in the area of the venipuncture site and
may need to be evaluated by a blood bank physician.
Informed Consent
• AABB Standards mandates that informed consent of allogeneic, autologous, and
apheresis donors be obtained before donation
• donor must be informed of the risks of the procedure and of the tests that are
performed to reduce the risk of infectious disease transmission to the recipient.
• donor must be able to ask questions concerning any element of the collection or
testing process.
• Minor donor or unable to comprehend the informed consent protocol, applicable
state law provisions will intercede.
Informed Consent
Pg. 292
 Autologous Donation
• An autologous donor is one who donates blood for his or her own use and
such a donor is referred to as the“donor-patient”
• Advantages: Decreased risk of disease transmission,
transfusion reactions, and alloimmunization.
• Disadvantages: higher cost due to added administrative
processes
 Autologous Donation
• There are various methods and techniques for obtaining autologous
blood, including:
ü Preoperative collection
ü Acute normovolemic hemodilution
ü Intraoperative collection
ü Postoperative collection
 Preoperative Collection

• Occurs during the 5 to 6 weeks immediately preceding a scheduled.

• Procedure might use preoperative autologous blood include orthopedic
procedures, vascular surgery, cardiac or thoracic surgery, and radical
prostatectomy.
• Some women do participate in an autologous collection
program during pregnancy for unforeseen complications.
 Preoperative Collection

• Preoperative autologous blood requires both an order from the patient’s

physician and an approval from the blood bank medical director.
• The maximal surgical blood order schedule (MSBOS) can provide guidance
for surgical procedures to estimate the number of units needed for
transfusion.
• The last blood collection should occur no later than 72 hours (3 days)
before the scheduled surgery to allow for volume replacement.
 Preoperative Collection
• Medical history and physical exam requirements for autologous donation are
less stringent than those for allogeneic donations.
• There is no minimum or maximum age requirement
• The minimum hemoglobin/hematocrit level is 11.0 g/dL and 33%, respectively.
• The donor-patient’s temperature should not be elevated or indicate any sign of
possible infection.
• Medical history questions can be limited to those needed to ensure the safety
of the donor.
 Preoperative Collection
• Most autologous donor units are a standard 450 or 500 mL ± 10%
• If the donor weighs less than 50 kg (110 lbs) the total amount of blood
collected must be reduced proportionately.
• If the amount of blood to be collected is determined to be 300 to 405 mL
for a 450 mL bag or 333 to 449 in a 500-mL bag, the unit must be labeled as
low volume.
 Preoperative Collection

• If the unit must be less than 300 mL, anticoagulant-preservative solution must
be adjusted and approval by the blood bank medical director is required.
• The collecting facility must determine the ABO and Rh of the blood
• If the collecting and the transfusing facilities are the same, then viral marker
testing is not required if they are different; These test must be repeated
(HBV DNA, HBsAg, anti-HBc, anti-HCV, anti-HIV-1/2,etc.)
 Acute Normovolemic Hemodilution

• Results in the collection of whole blood with the concurrent infusion of

crystalloid or colloid solutions, thus maintaining a normal blood volume but
decreasing the patient’s hematocrit.
• 1-2 units of the patient's blood are removed at the beginning of surgery and
replaced by volume expanders.
• The ratio of replacement is 3:1 for crystalloids and 1:1 for colloids.
 Acute Normovolemic Hemodilution

• A limited hemodilution will reduce the hematocrit to 28%

• Severe dilution will reach 21% or less. It is recommended that the patient start
with a hemoglobin of at least 12.0 g/dL.
• The procedure is performed in surgery immediately prior to beginning the
surgical procedure and is managed by anesthesiology.
• The blood is collected in standard blood bags containing anticoagulant
or preservative and is stored in the room at room temperature.
 Acute Normovolemic Hemodilution

• The blood is normally reinfused to the patient during or immediately following

the surgery, but within 8 hours of collection, thus maintaining the viability of
both platelets and coagulation factors.
• If the blood is not transfused during surgery, the blood can be stored a RT for
up to 8 hours or at 1-6°C for 24 hours.
• If the units leave the OR and are stored, they must be appropriately tested and
labeled as with preoperative autologous units.
 Intraoperative Collection

• Involves collecting shed blood from the surgical site

• Blood is washed it with saline to remove unwanted debris resulting RBCs with
hematocrit of 50% to 60%; and then reinfusing those cells immediately.
• This process is repeated continually during the surgical procedure.
• This type of collection has been used in cardiothoracic, major orthopedic, and
cardiac surgeries and etc.
 Intraoperative Collection

• Advantages: used in cases where preoperative donation is not possible

or when the patient cannot be scheduled for multiple preoperative
donations.
• Disadvantages: high cost of the instrumentation involved and training of
the personnel to run the instrument.
 Postoperative Blood Salvage

• Is collected from a drainage tube placed at the surgical site.

• It is reinfused, with or without processing, via a microaggregate filter to screen
out any debris
• It is recommended that no more than 1,400 mL be reinfused
• Blood must be reinfused within 6 hours of collection or it is to be discarded.
 Postoperative Blood Salvage

• Advantage:very low cost, and it can be used in conjunction with other

autologous blood collection procedures, there is no risk of the blood being
transfused to the wrong person.
• Disadvantage: It would not produce enough blood for the patient’s needs, it
carries a significant risk of producing febrile nonhemolytic transfusion
reactions
 Directed Donation
• Is a unit collected under the same requirements as those for allogeneic
donors, except that the unit collected is directed toward a specific patient.
• Tag for the directed unit is a distinct color (e.g.,yellow, salmon) to differentiate
it from autologous tags (Green)
• If the donor is a blood relative, The unit must be irradiated to prevent
transfusion-associated graft-versus-host disease (TA-GVHD)
 Apheresis Donation
• Is an effective mechanism for collecting a specific blood component while
returning the remaining whole blood components back to the patient.
• Apheresis instrument: automated cell separator device whose centrifugal
force separates blood into components based on differences in density.
• Apheresis can be used to collect platelets, plasma, white blood cells
(leukocytes), red blood cells, and stem cells.
 Apheresis Donation
• It is designed to collect large volumes of the intended component and is the
only effective method for collecting leukocytes and stem cells.
• The donor requirements for apheresis donation are generally the same as for
whole blood donation.
• The process is regulated by the FDA, and both AABB and the American Society
for Apheresis (ASFA) provide comprehensive guidelines and standards
 Plateletpheresis

• An apheresis platelet unit is equivalent to six to eight random donor platelets,

so a single product is a typical therapeutic dose for most adult patients.
• Plateletpheresis donors may donate more frequently than donors of whole
blood (8 weeks or 56 days).
• Interval between plateletpheresis donations is at least 2 days, not to exceed
more than twice a week or more than 24 times a year.
 Plateletpheresis

• Donors who have ingested aspirin, Feldene, or aspirin-containing medications

should be deferred for 48 hours
• Donors on Plavix (clopidogrel) or Ticlid (ticlopidine) should be deferred for 14
days after the last dose
• If RBCs were not able to be returned to the donor on the previous apheresis
procedure, the donor must be deferred for 8 weeks
 Plateletpheresis

• Although a platelet count is not required on the first donation, it is required

if the interval between donations is less than 4 weeks; in that case,
the platelet count must be above 150,000/μL.
• Donor reactions to plateletpheresis collections are most commonly a reaction
to the citrate or anticoagulant used in the procedure.
• Vasovagal and hypovolemic reactions are very rare but have been reported.
 Plateletpheresis

• Testing requirements are the same as for other allogeneic blood products,
including ABO group/Rh type, antibody screen, and infectious disease markers.
• If the donor is donating repeatedly for a specific patient, repeat testing need
only be done every 30 days.
• FDA guidelines require that the donation records of regular plateletpheresis
donors be reviewed by a physician at least every 4 months.
 Plasmapheresis

• Plasma was the first product to be collected by apheresis methods and was
primarily used as a method for collecting “source plasma,” which is further
manufactured into plasma derivatives.
• Plasmapheresis donors are classified as either “infrequent/occasional” or
“serial,” depending on the frequency of donations.
• Infrequent donor undergoes no more than one procedure in a 4-week period.
 Plasmapheresis

• Serial donors may donate more frequently than 4 weeks but no more than
every 48 hours and no more than two donations in a 7-day period.
• The donor requirements for both are the same as for allogeneic whole blood
donors,
• The RBC loss must not exceed 25 mL/week or 200 mL in an 8-week period. At
the start of a serial apheresis program and at 4-month intervals
 Plasmapheresis

• Donor must be tested for total serum/plasma protein levels and quantitative
immunoglobulin levels, and protein electrophoresis must be performed.
• The levels must remain in the normal range, or the donor must be removed
from the program until the levels return to normal.
• There should be two separate forms of identification so that both the donor
and the phlebotomist can verify.
 Leukapheresis

• Apheresis is the only effective method for collecting leukocytes or,

more specifically, granulocytes.
• In order to collect a large enough volume of leukocytes
(more than 1 × 1011 granulocytes), the donor must be given certain drugs
or sedimenting agents, and specific informed consent must be obtained
from the donor prior to administering these drugs.
 Leukapheresis

• AABB Standards states that any of these drugs or agents used to facilitate
leukapheresis will not be used on donors whose medical history suggests that
such a drug will exacerbate previous disease.
 Leukapheresis

• Hydroxyethyl starch (HES)

• which is a common sedimenting agent
• It enhances the separation of the WBCs from the RBCs during centrifugation
• Disadvantage: HES is a colloid; it expands the donor’s blood volume and
remains in the circulation for extended periods of time.
• As a result, caution must be taken to control the amount of HES given to a
donor and its accumulation in the donor’s circulation.
 Leukapheresis

• Corticosteroids (Prednisone or Dexamethasone)

• These drugs are given to the donor prior to the collection procedure.
• They work by pulling the granulocytes from the marginal pool into the general
circulation, thus increasing the supply of cells available for collection.
• Careful scrutiny must be used to obtain an accurate health history on the
donor to identify any medical condition that could be exaggerated by the
presence of corticosteroids.
 Leukapheresis

• Recombinant hematopoietic growth factors

• The advantages of these growth factors is that they can produce 4-8 times the
volumes of cells in each collection compared with other agents.
• Appear to be quite well tolerated by the donor.
• Each collection facility should develop policies outlining maximal doses of
stimulating agents used in leukapheresis with appropriate contraindications
for donors.
 Leukapheresis

• Each leukapheresis product must be tested for ABO group and Rh type as well
as the HLA type of the leukocytes.
• Most leukocyte concentrates are contaminated with some RBCs.
• If the amount of contaminating RBCs exceeds 2 mL, the product should be
crossmatched with the recipient, and a pilot tube sample must accompany the
product.
 Double RBC Apheresis

• In the 1990s, double units of red blood cells were collected using the apheresis
equipment.
• FDA finalized the guidance recommendations for this procedure in 2001.
• Double RBC apheresis can be used to collect either allogeneic or
autologous units.
• The donor must meet the requirements for whole blood donation and the
recommendations established by the equipment manufacturer.
 Double RBC Apheresis

• The volume of red blood cells removed from the donor should not yield a
donor hematocrit of less than 30% or a hemoglobin of less than 10 g/dL after
volume replacement.
• Donors participating in double RBC apheresis programs are deferred for 16
weeks following successful completion of the donation procedures.
• The donor can donate again within 8 weeks, provided all other donation
criteria are met.
 Double RBC Apheresis

• If the RBC loss is greater than 200 mL but less than 300 mL, the donor should
be deferred for 8 weeks.
• If the total RBCs lost is greater than 300 mL, the donor must be deferred for
the full 16 weeks.
WHOLE BLOOD COLLECTION
o Donor identification
o Aseptic technique
o Venipuncture
o Collection of pilot tubes and whole blood unit
o Post donation instructions
o Adverse donor reactions
DONOR IDENTIFICATION
• A numeric or alphanumeric system is used to link the donor to the donor record,
pilot tubes, blood container, and all components made from the original collection.

• Care must be taken to avoid:

ü Duplicate numbers
ü Voided numbers
ü Other mistakes in the labeling process
ASEPTIC TECHNIQUE
• For blood collection, most blood centers use an iodine compound such as:

ü PVP-iodine
ü Polymer iodine complex

• Using a tourniquet or blood pressure cuff, the venipuncture site is identified

• The area is scrubbed at least 4 cm in all directions from the site
for a minimum of 30 seconds.
ASEPTIC TECHNIQUE
• The area is then covered with a dry sterile gauze pad until the venipuncture is
performed.
• Donors who are allergic or sensitive to iodine compounds may use :

ü Chlorhexidine gluconate
ü Isopropyl alcohol
COLLECTION PROCEDURE
WHOLE BLOOD COLLECTION
PROCEDURE:
WHOLE BLOOD COLLECTION
PROCEDURE:
WHOLE BLOOD COLLECTION
PROCEDURE:
WHOLE BLOOD COLLECTION
PROCEDURE:
WHOLE BLOOD COLLECTION PROCEDURE:
POST-DONATION INSTRUCTIONS
• It is recommended that donors
remain in an area where they
can be observed by the
donation center staff and be
given instructions to follow for
the next 24 hours.
DONOR REACTION
o Mild
o Moderate
o Severe
o Hematomas
DONOR REACTIONS
Donor reactions cover a wide spectrum, from:
• Nervousness
• Hematomas at the phlebotomy site
• Convulsions
• Loss of consciousness.
DONOR REACTIONS
Reactions can generally be divided into three categories:
• Mild
• Moderate
• Severe
MILD
• Syncope or fainting • Twitching
• Nausea or vomiting • Muscle spasm
• Hyperventilation

The following instructions apply for a donor who has fainted:

1. Remove the tourniquet and withdraw needle
2. Place cold compresses on the donor’s forehead
3. Raise the donor’s legs above the level of the head
4. Loosen tight clothing and secure airway
5. Monitor vital signs
MILD
Donors who are extremely nervous may exhibit sudden twitching or muscle spasms:
• Conversing with the donor and having the donor breathe into a paper bag
• Not advised to give oxygen to these donors

If the donor starts to feel nauseated or vomits, the following instructions apply:
1. Instruct the donor to breathe slowly
2. Apply cold compresses to the forehead
3. Turn the donor’s head to one side and provide an appropriate receptacle
4. The donor may be given water after vomiting has ceased
MODERATE
• Loss of consciousness
• Decreased pulse rate
• Hyperventilate
• Fall in systolic pressure to 60 mm Hg

The following instructions apply:

1. Check vital signs frequently
2. Administer 95% oxygen and 5% carbon dioxide
SEVERE
• Convulsions

The following should be followed by the donor room personnel:

1. Call for help immediately and notify the blood bank physician
2. Try and restrain the donor to prevent injury to self or others
3. Ensure an adequate airway
HEMATOMAS
• Localized collection of blood under the skin resulting in a bluish discoloration
• Needle going through the vein, with subsequent leakage of blood into the tissue

If a hematoma develops, the following instructions apply:

1. Remove the tourniquet and needle from donor’s arm
2. Apply pressure with sterile gauze pads for 7 to 10 minutes,
with the donor raising his or her arm above the heart
3. Apply ice to the area for 5 minutes
DONOR RECORDS
DONOR PROCESSING
o ABO/Rh
o Antibody screening
o HBV
o HCV
o HIV
o HTLV-1/11
o WNV
o Syphilis
o T. cruzi (Chagas Disease)
o Zika and Ebola
 DONOR RECORDS
• Must be retained by the blood collection facility as mandated by the FDA
and AABB.
• Donor’s confidentiality is not compromised and that donor records are not altered.
• Policies on record-keeping and storage, and the blood bank staff should be well
trained on these policies and procedures.
• Minimum retention time for donor records varies
from 5 to 10 years to indefinitely
 DONOR PROCESSING
• The donor unit collected must be tested and processed by blood bank
technologists before it can be made available for transfusion.

• Tests performed on donor blood:

ü ABO/Rh ü HTLV-I/II
ü Antibody Screen ü WNV
ü HBV ü Syphilis
ü HCV ü T. cruzi (Chagas Disease)
ü HIV ü Zika and Ebola
ABO/Rh:
• ABO group must be determined by testing the donor RBCs with anti-A and anti-B reagents
and by testing the donor serum or plasma with reagent A1 cells and B cells.
• The donor’s Rh type should be determined by testing with anti-D reagent at the immediate
spin phase. In the event the initial testing is negative, a test for weak D must be performed.
- 37°C incubation
- Antihuman globulin (AHG)
• If both the immediate spin and weak-D test results are negative:
- Rh - negative
• Positive test for D:
- Rh - positive
ANTIBODY SCREENING:
• AABB Standards requires that donors with a history of pregnancy or transfusion be tested for
unexpected antibodies to RBC antigens.
• Most blood centers choose to perform the antibody screen test on all donors.

TEST:
• Antibody screen is performed on a recipient prior to transfusion (two or three individual reagent cells)
• Testing of donor units generally uses a pooled cell reagent (reagent contains two or three individual
cells pooled into a single reagent.)

The pooled screening cell reagent:

• Contains all of the required antigens.
• Capable of detecting the presence of the clinically significant alloantibodies.
• Control system must be in place for the method used.
HBV: Hepatitis B virus
• Approximately 240 million people are chronically infected with HBV
• In 2016, the FDA recommended the implementation of HBV DNA to testing regimens
already in place (anti-HBc, (IgG and IgM) and HbsAg)

TEST: Anti-HBc, (IgG and IgM) and HbsAg:

• A donor’s blood may be used for transfusion if all three screening tests are nonreactive.
• If three assays are reactive, the donor’s blood must not be used for transfusion.
• A donor who was repeatedly reactive with anti-HBc on more than one occasion may be
• considered for reentry if after 8 weeks the HBsAg, anti-HBc, and HBV NAT
were negative.
HCV: Hepatitis C Virus
• Identified in 1988 and was initially referred to as non-A, non-B (NANB) hepatitis.
• Screening tests for anti-HCV involves:
- enzyme immunoassay (EIA)
- Chemiluminescent immunoassay (ChLIA) methods.
• 1999, NAT (Nucleic Acid Amplification Test) for HCV RNA was introduced
• 2002 the tests were licensed by FDA and mandated for routine donor screening in
addition to the EIA or ChLIA methods.
 HCV: Hepatitis C Virus
Nucleic Acid Amplification Test:
• Able to detect small amounts of viral nucleic acid in blood before antibodies or viral proteins
such as HCV core antigen are detectable by current methods.
• Effectively reduced the window period for detection of HCV by approximately 70%, from a
mean of 82 days to 25 days
Confirmatory methods:
• RIBA (recombinant immunoblot assay)
• HCV RNA
- Positive by RIBA is considered to have the HCV antibody and would be indefinitely
deferred as a blood donor.
HCV: Hepatitis C Virus
Donors who repeatedly test reactive for HCV screening tests must be deferred, and
the components or products prepared are discarded.
Reentry protocol for HCV:
• FDA utilizes two groups of donors.
- One group is identified as being NAT reactive with a negative anti-HCV test
- Second group as NAT nonreactive or not done, anti-HCV repeat reactive, and
RIBA indeterminant, negative, or not done.
HCV: Hepatitis C Virus
• Follow-up of 6 months and using HCV NAT and anti-HCV, if the NAT results are
reactive and anti-HCV repeat reactive, the donor is deferred permanently
• Likewise, if the NAT is reactive and anti-HCV negative, the donor is permanently
deferred.
• NAT is nonreactive and anti-HCV repeat reactive, the donor is deferred and
followed up at a later time.
• NAT is nonreactive and anti-HCV negative, the donor may be reentered
for a future donation.
HIV: HUMAN IMMUNODEFIENCY
• All donor units must be screened for the presence of the human
immunodeficiency virus (HIV-1/2) antibody using an FDA-approved method and
HIV-1 RNA.
• initial screening tests are negative = unit is suitable for transfusion
• if positive = test must be repeated in duplicate; If any one of the duplicate tests
is reactive, the unit must be discarded
 HIV: HUMAN IMMUNODEFIENCY
TEST:
• Screening tests include EIA, ChLIA, and NAT. Minipool (MP)-NAT is run using 16 to
24 donation samples per pool.
- If the pool is nonreactive all units may be released for transfusion.
- If the pool is reactive, then units are tested individually using NAT.
• Any reactive units identified for HIV-1 should undergo a confirmation test.
• Confirmation tests for HIV include the Western blot and the
immunofluorescence assay (IFA).
HIV: HUMAN IMMUNODEFIENCY
• For donor reentry, the FDA utilizes three possible groups.
- Group 1 is NAT reactive, Anti-HIV-1/2 negative, HIV-1 EIA negative
- Group 2 is NAT nonreactive or not done, antiHIV-1/2 repeat reactive, HIV-1 WB
or IFA indeterminate, unreadable, negative, or not done.
- Group 3 is NAT nonreactive or not done, anti-HIV-1/2 negative, HIV-1 EIA repeat
reactive, neutralization test positive or indeterminate.
HIV: HUMAN IMMUNODEFIENCY
If a donor is classified as being in one of these groups, the donor is followed up in 8
weeks and tested using HIV-1 NAT and an anti-HIV-1/2 test.
• Donor is permanently deferred if the NAT is reactive and the anti-HIV-1/2 is repeat
reactive or the NAT is reactive and the anti-HIV-1/2 test is negative.
• Donor is deferred and followed up if the NAT is nonreactive and the anti-HIV-1/2
is repeat reactive.
• Donor is reentered for future donation if the NAT is nonreactive and the
anti-HIV-1/2 is negative.
 HTLV-I/II: HUMAN T-cell lymphotrophic virus
• HTLV-I virus, or human T-cell lymphotrophic virus type I, is the causative agent of adult
T-cell leukemia
• Associated with a neurological disorder called HTLV associated myelopathy
• Persons can contract both viruses from transfusion via infected lymphocytes.
• In recipients of blood infected by HTLV-I and II, 20% to 60% will develop infection.
• Myelopathy can occur in a person infected with these viruses as a result of blood
transfusion
• There is no approved protocol for donor reentry involving HTLV-infected donors.
HTLV-I/II: Human T-cell lymphotrophic virus
• HTLV-I:
- Began in 1988
- Combined HTLV-I/II assay was approved 10 years later in 1998
• HTLV-II:
- Been shown to have about 60% homology with type I
- Prevalent among intravenous drug users in the United States.
• TESTS:
- IFA
- Western blot
West Nile virus (WNV)
• Arthropod-borne virus involving the natural reservoir host (birds)
and the intermediate host (mosquitos), which can infect a human.
• Humans are dead-end hosts
• First detected in the United States in 1999 in New York City
• Symptoms of disease include headache, myalgia, arthralgia, rash, or
gastrointestinal symptoms.
• Testing for WNV began in 2003, and in 2009
West Nile virus (WNV)
TEST:
• aMP-NAT or individual donor (ID-NAT) method.
• MP-NAT uses pools of 6 to 16 donor samples (routinely used when risk of WNV
infection in the geographical area is low)
• Switch to the ID-NAT format is recommended when the risk is high.
• If an MP is reactive, each sample in the pool should be retested individually.
• If an MP is reactive, each sample in the pool should be retested individually.
• Any individual units with reactive test results should be discarded, and the donor
should be deferred from further donations for 120 days.
Syhilis
• Screening tests include the rapid plasma reagin (RPR) and the Venereal
Disease Research Laboratory (VDRL) test (cardiolipin particles)
• Cardiolipin-like antibodies have been documented in persons with
untreated syphilis infections.
• Antibody will agglutinate cardiolipin carbon particles in the form of
visible flocculation.
• In this test, indirect immunofluorescence is used to detect antibodies to
the spirochete T. pallidum, the agent that causes syphilis
Syhilis
TEST:
• FTA-ABS
• fluorescent treponemal antibody absorption test.
- If STS or VDRL screening test is reactive or indeterminate, the components from
that donation must be discarded
- If the FTA-ABS test is non - reactive, the donor may be reentered and the
components labeled as reactive with the screening test.
- Donor of a confirmed reactive test may be reentered into the donor pool
after 12 months
T. cruzi (Chagas Disease)
• Chagas disease is a parasitic infection that is endemic to Mexico and Central
and South America.
• Infection is generally mild, but it persists, without symptoms, throughout the
infected individual’s life and can be transmitted through blood transfusions.
• FDA first recommended testing donors for antibodies to T. cruzi in 1989, but it
wasn’t until December of 2007 that an EIA test was licensed
• All donors (allogeneic and autologous) are to be tested once.
T. cruzi (Chagas Disease)
TEST:
• If the results are nonreactive, the donor need not be retested with each
donation.
• Repeat reactive donors must be deferred indefinitely and the products
quarantined and destroyed.
• No approved confirmatory tests are available, so there are no mechanisms for
re-entry for deferred donors.
Zika Virus
• Zika is an RNA virus and spread by the bite of an infected Aedes mosquito, namely A.
aegypti and A. albopictus.
• Currently, there is no vaccine for Zika
• The virus can also be transmitted via blood transfusion, from mother to fetus, and by
sexual intercourse.
• Symptoms include fever, rash, headache, joint and muscle pain, and redness of eyes.
• FDA recommends potential donors who have been infected with Zika not donate blood
for 4 weeks
Zika Virus
TEST:
• Blood collections should cease in areas of the United States with active Zika
transmission unless they can be screened by NAT or treated with pathogen-
reduction technology (PRT).
• The Cobas Zika ID-NAT (Roche Diagnostics, Indianapolis, Indiana) test has been
employed in Puerto Rico
Ebola Virus
• Caused by infection of the Ebola virus, which is part of the Filoviridae family
• Virus was first described in 1976 near the Ebola River in the Congo.
• Transmission occurs via exposure to blood or body fluids, contaminated
needles, and infected primates.
• Symptoms include fever, headache, muscle and abdominal pain, fatigue,
diarrhea, vomiting, and unexplained hemorrhaging.
• Like Zika, there is no approved vaccine to prevent Ebola.
• Category A bioterrorism agent/disease.
Ebola Virus
TEST:
• DHQ should include questions assessing a history of close contact in the past 8
weeks with an individual confirmed to have Ebola infection or disease or an
individual who is suspected as having Ebola.
• Regarding deferral periods, the FDA recommends an indefinite deferral for a
donor with a history of Ebola virus infection or disease as well as an 8-week
deferral
 END

THANK YOU!

Amoguis, Cris Daniel Cahapay, Nathaniel Joshua Guibelondo, Lyndie Kia Makinano, John Renier