IMHM311-LEC
WEEK #10: DONOR SCREENING
MIDTERM I SECOND SEMESTER
Governing Agencies
The agencies charged with regulating processes and procedures
in the immunohematology laboratory include the:
• AABB ➔ American Association of Blood Banks
• FDA➔ U.S. Food and Drug Administration
• CAP ➔ College of American Pathologist
• JCAHO➔ Joint commission on Accreditation of Healthcare
Organization
• Now known as TJC (The Joint Commission) → responsible
in maintenance of the physical facilities of blood bank
The first two governing agencies (AABB and FDA) are more
specifically involved in donor screening regulations and are
described in the following paragraphs. All organizations conduct
inspections of hospital blood banks by reviewing policies and
procedures for accreditation purposes.
AABB
• Established in 1947
o 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.
• An international association of blood banks that includes
hospital and community blood centers, transfusion and
transplantation centers, and individuals involved in
transfusion medicine.
o Stand-alone transfusion medicine facilities is included.
• The AABB has published books on transfusion medicine
throughout its existence; two resources that are vital to donor
screening procedures are:
1. AABB Standards
2. AABB Technical Manual
• Man-Power/Members of the Organization consist of:
o Medical laboratory technicians
o Medical technologists
o Registered nurses (point-of-care)
o Laboratory managers (called as Chief Medical
Technologist in PH)
o Physicians (counsel to donors)
o Transfusion medicine fellows and
o Researchers involved in transfusion medicine.
FDA
• Inspection of the Blood Bank center on an annual basis.
• Regulations for donor screening are outlined in the “Code of
Federal Regulations (CFR)”.
o Under the auspices of the FDA, blood is regarded both
as a biologic and a drug.
• 1988: CBER was formed
o CBER is responsible for regulating the collection of
blood and blood components used for transfusion and
for the manufacture of pharmaceuticals derived from
blood and blood components.
o CBER→ Center for Biologics Evaluation and Research
• Additional Notes:
o CBER develops and enforces quality standards,
inspects blood establishments, and monitors reports of
errors, accidents, and adverse clinical events.
o In the early 1990s the FDA began to treat blood
establishments such as manufacturers, requiring strict
compliance toward all aspects of transfusion medicine
including donor selection and screening.
o The FDA differs from the AABB in that the former is
responsible for licensing of reagents and blood
products as well as blood center inspections.
Blood Bank vs. Blood Center
• Confusion exists and terms are sometimes used
inappropriately
• Blood bank in a hospital is also known as the transfusion
service, performs compatibility testing and prepares
components for transfusion.
• Blood Center is the donation center, screens donors,
draws donors, performs testing on the donor blood, and
delivers appropriate components to the hospital blood bank.
Donor Screening
• Medical History of the donor
o As a medical technologist, we need to accompany all of
the donors regarding this matter. We need to have an
assurance that the patients are safe on the specific day
before they can donate. Conduct an interview, donor
should not hide anything. The goal of this process is to
have a safe and efficacious blood products towards to
our patient.
• (mini) Physical examination
o appearance/physical characteristics
• Serologic testing of the donor
Nicole Anne Mamorno
o In case a patient test positive on a specific test without
his/her knowledge about the disease, confirmatory test
must be done.
Note: Any one of these areas may preclude a potential donor from
the donation process.
Medical History and Physical Exam
• The medical history information and physical
examination are designed to answer two questions:
o (1) Will a donation of approximately 450 mL of whole
blood at this time be harmful to the donor?
▪ The goal is to protect the donor from harmful
event.
▪ We have the right to accept and deferred as a
medical technologist.
o (2) Could blood drawn from this donor at this time
potentially transmit a disease to the recipient?
▪ The goal is to protect the patient that will receive
the blood products.
Registration
Necessary information that we need to get from the donors:
• Name (Full name)
• Date and Time of Donation
• Address
• Telephone/Contact number:
• Gender
• Age or date of Birth:
o ALLOGENEIC VS. AUTOLOGOUS
▪ ALLOGENEIC DONATION ➔ ≥17 Yrs. Old
✓ The minimum age for an allogeneic donation
is 17 years; there is no upper age limit.
▪ AUTOLOGOUS DONATION➔
✓ For autologous donation (donating blood to
be used for oneself [donor-patient]), there is
no age restriction; however, each donor-
patient must be evaluated by the blood bank
medical director.
• Consent to Donate
o Donors should be given educational materials informing
them of the risks of the procedure.
o Signs and symptoms associated with the human
immunodeficiency virus infection and AIDS, and the
opportunity to decline from the donation process if they
believe their blood is not safe or they are uncomfortable
with the procedure.
Additional information that may be helpful includes the donor’s
social security number, the name of the patient for whom the blood
is intended (directed donation), race of the donor for unique
phenotypes, and cytomegalovirus (CMV) status. The latter may be
helpful because some patient groups (e.g., neonates) require
CMV-negative blood in certain circumstances.
Medical History Questionnaire
• Obtaining an accurate medical history of the donor is
essential to ensure benefit to the recipient.
o The medical history questions have been developed
and revised as necessary by the AABB and FDA.
• The interviewer should be familiar with the questions, and the
interview should be conducted in a secluded area of the
blood center.
• The questions are designed so that a simple “yes” or “no” can
be answered but elaborated if indicated.
• The medical history is conducted on the same day as the
donation.
• Medications the donor taking are present in plasma, may
cause deferral.
o Medication for acne
• Infections the donor has may be passed to recipient, may be
cause for deferral.
• Intimate questions: questions regarding HIV and HBV risks,
other questions about sexual intercourse with people etc.
Blood Donation Deferral
• Patient may be deferred from donating blood and tagged as
permanent deferral, Temporary deferral, 3 years deferral,
one-year/ 12 months deferral, 4 weeks/ 1 month deferral, 2
weeks deferral, 48 hours deferral, etc…
PERMANENT DEFERRAL / INDEFINITE DEFERRAL
• A donor who has been hospitalized for:
o AIDS,
o Persons with clinical or laboratory evidence of HIV
infection,
o Tegison or etretinate intake,
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 WEEK 10: DONOR SCREENING
o confirmed positive test for HBsAg after the 11th birthday
confirmed positive test for hepatitis B surface antigen
(HBsAg),
o A person with a history of hemophilia A or B,
o von Willebrand’s disease, or severe thrombocytopenia
must be permanently deferred,
o Positive HTLV 1 or 2,
o A history of babesiosis or Chagas’ disease is cause for
indefinite deferral,
o Positive hepatitis C test result,
o Positive anti-HBc test result,
• Men who have engaged in sex with another man since
1977 should be permanently deferred; Stickers:
o Men or women who have engaged in sex for money or
drugs since 1977 and persons who have engaged in sex
with such people during the preceding 12 months should
not donate blood or its components.
o Latent stage of HIV: about 3-20 years
• Skin lesions: Prior to donation, the donor’s arms should be
inspected for skin lesions. Evidence of skin lesions (e.g.,
multiple puncture marks) is cause for indefinite deferral.
o Skin disorders that are not cause for deferral include
poison ivy and other rashes; these, however, should be
evaluated by a blood bank physician.
TEMPORARY DEFERRAL
• Taking antibiotics for an infection or for prophylaxis after
dental surgery, If viral hepatitis before the age of 11 year
• active disease under the treatment such as cold, flu,
tuberculosis, syphilis, infections, curable disease of the
heart, lung, kidney, liver and GI tract
THREE YEARS DEFERRAL
• Persons who have been treated for malaria should be GENERAL APPEARANCE:
deferred for 3 years following therapy.
• Those who have had malaria, immigrated from, or lived in an
endemic area are deferred for 3 years
o Malarian endemic area in the Philippines: Palawan,
Mindoro, Sulu, Sultan Kudarat BODY WEIGHT:
ONE-YEAR / 12 MONTHS DEFERRAL
• Persons who have had sex with any person who is a past or
present IV drug user.
• Persons who have had sex with any person with hemophilia
or related blood disorder who has received factor
concentrates should be deferred for 12 months.
o Coagulation disorders
• Women who have had sex with men who have had sex with
another man even once since 1977
• Donors who have been exposed to blood or body fluids via
an accidental needlestick or other injury.
• Person who received a tattoo.
• Person who received blood transfusion, other human tissues.
• Syphilis or gonorrhea or treatment for either or a reactive
screening test for syphilis should be deferred for 12 months
o RPR or Rapid Plasma Reagin Test (positive = 12
months deferral)
• A person who has been subjected in a correctional institution
in the past 12 months.
• Individuals who have been incarcerated for more than 72
consecutive hours during the previous 12 months be
deferred for 12 months from their last date of incarceration
• Vaccination against Hepatitis B, Anti-Rabies vaccination
8 WEEKS / 56 DAYS DEFERRAL
• Allogeneic blood donations or allogenic donors
4 Weeks / 1 month Deferral
• Live attenuated vaccination against German measles
(rubella) or chickenpox.
• Taking drugs like Accutane or Proscar should be deferred
from donating blood for at least 1 month after the last dose.
2 WEEKS DEFERRAL
• Donor receiving a live attenuated or bacterial vaccine such
as measles (rubeola), mumps, polio, typhoid, or yellow fever,
there is a 2-week deferral.
3 DAYS DEFERRAL
• Piroxicam, aspirin or anything with aspirin. (Blood thinners)
• Undergo pheresis
48 HOURS DEFERRAL
• Apheresis blood donation
TEMPERATURE:
12 HOURS DEFERRAL
• Alcohol intake
Nicole Anne Mamorno
Confidential Unit Exclusion (CUE)
• Although CUE is not mandated by the AABB Standards or
the FDA.
o most blood centers include the CUE as part of the
donation process.
• The CUE provides;
o an opportunity for those donors who felt pressure to
donate in the workplace or at a community blood drive
to indicate their blood should not be transfused.
• There are many ways this can be carried out; most
procedures avoid face-to-face contact with the donor
representative for answering the question “should my blood
be used for donation?”
• USE: the blood may be given to another (for the recipient)
• DON’T USE: The blood will not be given to another (it will
be destroyed)
PHYSICAL EXAMINATION
• Provides a general screening of health and vital signs to
ensure good health on the day of donation.
o Blood pressure
o Temperature
• The donor should appear in relative good health to the
trained donor historian.
• Specific screening assessments are performed and the
results are recorded in the donor record.
• The donor center representative should observe the
prospective donor for presence of excessive anxiety, drug or
alcohol influence, or nervousness.
• Standards mandates a maximum of 10.5mL/Kg of donor
weight for whole blood collection inclusive of pilot tubes for
testing. (STIs, etc.)
o If the donor weighs less than 110 pounds, the
amount of blood collected must be proportionately
reduced as well as that of the anticoagulant.
o Hence:
▪ Volume of Blood to be extracted: should be less
▪ Volume of anticoagulant: should be altered
▪ Volume of anticoagulant to be removed from the
blood bag:
STANDARD COMPUTATION FORMULA/S:
• Amount of blood to be drawn:
𝐷𝑜𝑛𝑜𝑟′𝑠 𝑤𝑒𝑖𝑔ℎ𝑡 (𝑙𝑏) 𝑥 450 𝑚𝐿
= 𝐴𝑙𝑙𝑜𝑤𝑎𝑏𝑙𝑒 𝑎𝑚𝑜𝑢𝑛𝑡 (𝑚𝐿)
110 𝑙𝑏
• Amount of anticoagulant needed:
𝐴𝑙𝑙𝑜𝑤𝑎𝑏𝑙𝑒 𝑎𝑚𝑜𝑢𝑛𝑡
𝑥 14 = 𝐴𝑛𝑡𝑖𝑐𝑜𝑎𝑔𝑢𝑙𝑎𝑛𝑡 𝑛𝑒𝑒𝑑𝑒𝑑 (𝑚𝐿)
100
• Amount of anticoagulant removed:
63 𝑚𝐿 − 𝑎𝑛𝑡𝑖𝑐𝑜𝑎𝑔𝑢𝑙𝑎𝑛𝑡 (𝑚𝐿)
= 𝐴𝑛𝑡𝑖𝑐𝑜𝑎𝑔𝑢𝑙𝑎𝑛𝑡 𝑡𝑜 𝑟𝑒𝑚𝑜𝑣𝑒 (𝑚𝐿)
SAMPLE PROBLEM: THE donors WEIGHT IS 100Lbs.
• What is the amount of blood to be drawn?
100 𝑙𝑏𝑠 𝑥 450 𝑚𝐿
𝑨𝒎𝒐𝒖𝒏𝒕 𝒐𝒇 𝑩𝒍𝒐𝒐𝒅 = = 𝟒𝟎𝟗. 𝟏𝟎 𝒎𝑳
110 𝑙𝑏𝑠
• How much anticoagulant is needed?
409.10
𝑨𝒎𝒐𝒖𝒏𝒕 𝒐𝒇 𝑨𝒏𝒕𝒊𝒄𝒐𝒂𝒈𝒖𝒍𝒂𝒏𝒕 = 𝑥 14 = 𝟓𝟕. 𝟐𝟕 𝒎𝑳
100 𝑙𝑏𝑠
• How much anticoagulant should be removed?
𝑨𝒎𝒐𝒖𝒏𝒕 𝒐𝒇 𝑨𝒏𝒕𝒊𝒄𝒐𝒂𝒈𝒖𝒍𝒂𝒏𝒕 𝒕𝒐 𝑹𝒆𝒎𝒐𝒗𝒆
= 63 𝑚𝐿 − 57.27 𝑚𝐿 = 𝟓. 𝟕𝟑 𝒎𝑳
• Standards mandates the donor temperature must be less
than or equal to 37.5oC or 99.5oF.
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 WEEK 10: DONOR SCREENING
• Donors are asked not to drink coffee or hot beverages while
waiting to donate as this may affect the temperature on
occasion.
• Oral temperatures that are lower than normal are not cause
for deferral.
PULSE RATE: 50-100 bpm
• The pulse of the donor should be between 50 and 100 bpm.
• Often, a donor who is athletic will have a pulse less than 50
bpm, which is not cause for deferral.
• The pulse should be counted for at least 15 seconds; any
irregularities should be evaluated by a blood bank
physician.
BLOOD PRESSURE:
• The systolic blood pressure of a potential donor should be
less than or equal to 180 mm Hg and the diastolic less
than or equal to 100 mm Hg.
• Blood pressure readings above these levels should be
evaluated by a blood bank physician.
HEMOGLOBIN CONCENTRATION:
• The hemoglobin level of the donor should be greater than
or equal to 12.5 g/dL, and the hematocrit level greater than
or equal to 38% for allogeneic donation.
o For autologous donation, the hemoglobin/hematocrit
level should be greater than or equal to 11 g/dL and
33%, respectively.
• The methods used for measuring hemoglobin include the
copper sulfate method or point-of-care instruments using
spectrophotometric methodology.
o Mobile blood donation
o CuSO4 (Copper Sulfate) Method: for hemoglobin/Hgb
▪ Specific Gravity of 1.053 pH
▪ Contains 30 mL per container
▪ Used for maximum of 25 tests
▪ Solution is disposable; easily dispose after used
▪ It should be sink within 15 seconds
▪ Remember!!! Dapat lumutang yung CuSO4 →
means accepted yung concentration ng donor or
acceptable blood kapag lumutang na yung
Copper Sulfate within 15 seconds. Okay?
• Hematocrit level can be measured manually by
centrifugation or by computing from the RBC count and
MCV result.
o RBC indices: MCV, MCH, MCHC
o Note: A hematocrit or packed cell volume can be
determined manually by centrifugation or calculated
using the RBC count and mean corpuscular volume;
blood is usually acquired via a finger stick.
NOTE:
SKIN LESIONS: (from the book, included din ‘to sa permanent
deferral)
• Prior to donation, the donor’s arms should be inspected for
skin lesions.
• Evidence of skin lesions (e.g., multiple puncture marks) is
cause for indefinite deferral.
• Skin disorders that are not cause for deferral include poison
ivy and other rashes; these, however, should be evaluated
by a blood bank physician.
Autologous Donation (Donor-patient)
• An autologous donor is one who donates blood for his or
her own use.
• Safer than allogeneic blood.
• There is no risk of disease transmission, transfusion
reactions, or alloimmunization to white blood cells, RBCs,
platelets, or plasma proteins.
• Autologous units are labeled differently than allogeneic
units and directed units. The former generally have a
distinct green label and tag.
• There are four different types of autologous donation:
o Preoperative collection
o Acute normovolemic hemodilution
o Intraoperative collection
o Postoperative collection
FIGURE 11–7 Autologous donation label.
(LifeSouth Blood Center, Montgomery, AL)
Nicole Anne Mamorno
Preoperative Collection
• Indications for preoperative collection include patients
undergoing orthopedic procedures, vascular surgery,
cardiac or thoracic surgery, and radical prostatectomy.
• The last blood collection should occur no sooner than 72
hours before the scheduled surgery to allow for volume
repletion.
• A minimum hemoglobin/hematocrit level of 11 g/dL and 33
percent.
• No deferral of the donor-patient except when there is a risk
of bacteremia.
o Bacteremia causes sepsis when it comes to donor
Acute Normovolemic Hemodilution (ANH)
• This type of autologous collection involves removal of whole
blood from a patient with infusions of crystalloid or
colloid before surgical blood loss.
• In one case, a 65-year-old patient scheduled for a radical
prostatectomy underwent an ANH. Approximately 2360 g of
blood was removed and replaced with 1500 mL of colloids
and 2000 mL of crystalloid solution. Retransfusion was
started after a blood loss of 1800 mL.
o The patient remained hemodynamically stable
throughout the operation.
Intraoperative Collection
• This type of autologous collection involves collecting and
reinfusing blood lost by a patient during surgery.
• Most programs use devices that are capable of collecting the
shed blood, washing it with saline, and then concentrating
the RBCs with hematocrits in the range of 50 to 60
percent.
• The vacuum setting on the device should be less than 100
torr to guard against possible hemolysis of recovered blood.
• This type of collection has been used in cardiothoracic,
major orthopedic, and cardiac surgery and vascular
surgeries such as liver transplantation.
• Several studies have associated Intraoperative Collection
are also intended Disseminated Intravascular
Coagulation (DIC) with shed blood that has undergone
coagulation/fibrinolysis and hemolysis.
• Downside of Intraoperative collection → For this reason,
intraoperative blood collection is contraindicated when
procoagulants are applied to the surgical field; special
attention should be paid to contact surfaces in the collection
process that may precipitate coagulation.
Postoperative Collection
• Blood is collected from a drainage tube placed at the
surgical site.
• This blood is characterized as being dilute, partially
hemolyzed, and defibrinated.
• It is recommended that no more than 1400 mL be
reinfused.
• Blood must be reinfused within 6 hours of collection or it
is to be discarded.
o Baka prone sa bacteremia magkaroon pa ng sepsis
kaya discard mo na.
Directed Donors
• A 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.
• A tag should be placed on the blood bag to indicate its use.
FIGURE 11–8 Directed donation tag.
(LifeSouth Blood Center, Montgomery, AL)
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 WEEK 10: DONOR SCREENING
Pheresis Donation
Pheresis means that there are only specific products/blood
component that we can get from the blood bag. A pheresis donor
may be characterized into one or all of the following:
1) Plateletpheresis
• The interval between donations is at least 2 days, not to
exceed more than twice a week or more than 24 times a
year.
• Donors who have ingested aspirin or aspirin-containing
medications are deferred. → since aspirin is a blood
thinner
2) Plasmapheresis
• A plasmapheresis donor may be characterized as either
“occasional” or “serial.”
• In the former, the donor undergoes pheresis not more often
than once every 4 weeks, and donor selection mimics that
of whole blood collection; in the latter, donation is more
frequent than once every 4 weeks, and additional
requirements apply.
3) Leukopheresis
• Special agents are required in the procedure for collection
of granulocytes from the leukopheresis donor.
o These may include hydroxyethyl starch,
corticosteroids, or growth factors such as
granulocyte-colony stimulating factor (G-CSF).
o The informed consent must include specific permission
for any of these agents used in the procedure.
o AABB Standards states that any of these drugs or
agents used to facilitate leukopheresis will not be used
on donors whose medical history suggests that such a
drug will exacerbate previous disease.
4) Double RBC pheresis
• Both the AABB and FDA have approved procedures for
removal of two allogeneic or autologous RBC units every 16
weeks by an automated method.
o The specifications for these donors are based primarily
on weight, height, and hematocrit level.
o For male donors, weight must be at least 130 pounds,
and height 5’1”;
o For females, weight of at least 150 pounds, and height
5’5”.
o The hematocrit level for both sexes must be a
minimum of 40 percent.
5) Stem cell pheresis
Whole Blood Collection, Donor Identification
Whole blood Collection
• This procedure is to be done only by trained personnel
working under the direction of a qualified licensed
physician.
o This section describes the identification of the donor,
aseptic technique, venipuncture, collection of pilot tubes
and whole blood unit, postdonation instructions, and
adverse donor reactions.
Donor Identification
• A numeric or alpha numeric system is used to link the
donor to the donor record, pilot tubes, blood container, and
all components made from the original collection.
o For example, si Pete nagdonate tapos siya pinaka-
unang donor so when it comes to the alpha numeric
system siya ay 1A, so lahat ng connected sakanya ay
1A. Hindi pwede mabago like 2A, NO…1A lang. OK?
• Care must be taken to avoid duplicate numbers, voided
numbers, or other mistakes in the labeling system. These
must be investigated and kept on record.
o We should have a standardized alpha numeric system
in line with blood donor identification.
• AABB Standards states that the trained phlebotomist must
identify the donor record and ensure that the donor name and
identification numbers match.
o Just like in the process of venipuncture, the
phlebotomist should ask the donor to state and/or spell
his or her name. At this time, the phlebotomist can
attach all labels to blood bags, donor record, and pilot
tubes.
Aseptic technique
• most blood centers use an iodine compound such as PVP-
iodine (Polyvinylpyrrolidone Iodine) or Polymeriodine
Complex.
• Done through a circular outward motion
• Using a tourniquet or blood pressure cuff, the venipuncture
site is identified, and the area is scrubbed at least 4 cm in all
directions from the site for a minimum of 30 seconds.
• 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 chlorhexidrine
gluconate and isopropyl alcohol. All methods must be
approved by the FDA.
Nicole Anne Mamorno
Collection Procedure
1. Confirm donor identity, and make the donor as comfortable as
possible.
2. Select a firm large vein in the antecubital space that is free of
any skin lesions or scarring. Both arms should be inspected.
o Deferred na agad kapag manipis yung ugat para di
aksayado sa blood.
3. Prepare the site using an FDA-approved cleansing method.
4. Inspect the blood bags for any defects or discoloration.
5. Ensure the balance system is adjusted to the volume being
drawn; ensure counterbalance is level. Place hemostats on
the tubing to prevent air from entering the line.
o Convert it with 1.06g/mL to counterbalance the weight
of the container and anticoagulant.
6. Reapply tourniquet or blood pressure cuff (40 to 60 mm Hg)
to increase distention of the vein.
7. Uncover the sterile gauze, and perform the venipuncture
immediately. Check the position of the needle, and tape the
tubing to the donor’s arm to hold needle in place. Cover with
a sterile gauze.
8. Release the hemostat, and ask the donor to open and close
hand every 10 to 12 seconds during collection procedure.
9. Reduce the pressure on the cuff to approximately 40 mm
Hg.
10. Continue to monitor the patient throughout the entire
collection process. The donor should never be left
unattended. Mix blood and anticoagulant periodically during
the procedure. (e.g., every 45 seconds)
11. When the primary bag has tripped the scale, the donor can
stop squeezing, and tubing can be clamped.
o A unit containing a volume of 405 to 550 mL should
weigh between 429 to 583 g plus the weight of the
container and anticoagulant.
o The conversion 1.06 g/mL is used to convert grams to
mL.
o If the volume collected is in the low volume range (300
to 404 mL), the unit must be labeled as a Low Volume
Unit and fresh frozen plasma (FFP) cannot be made
from this unit as it would not contain adequate levels of
coagulation factors.
12. Before the needle is removed from the donor’s arm, pilot
tubes are filled. The pressure is reduced to 20 mm Hg or
less and, depending on the tubing of the bag, the tubes are
filled:
o In-line needle. A hemostat or metal clip is used to seal
tubing distal to the needle. The connector is opened, the
needle is inserted into the pilot tube, the hemostat is
removed, and tubes are filled. The donor needle can
now be removed.
o Straight-tubing assembly. Place hemostats
approximately four segments from the needle. Tighten
the loose knot made previously in the tubing; release the
hemostats, and strip a segment of tubing between knot
and needle. Secure hemostat and cut tubing in stripped
area of segment. Fill required tubes by releasing
hemostats. This is an open system, and appropriate
biohazard precautions should be followed. Reapply
hemostats and remove needle from donor’s arm.
13. Once the needle has been removed from the donor’s arm,
apply pressure over gauze, and ask the donor to raise his or
her arm, continuing to exert pressure over the site. When the
bleeding has stopped, the donor can lower his or her arm, and
an appropriate bandage can be applied.
14. The needle assembly should be discarded into an
appropriate biohazard receptacle. The tubing should be
stripped to allow proper mixing of anticoagulant/preservative
with blood.
15. Make a hermetic seal to the segments, and apply an
appropriate identification label to one segment for storage. A
dielectric sealer is generally used for heat sealing. Place
blood at the appropriate temperature. Units in which platelets
will be made must be stored at room temperature (20oC to
24oC); all others can be stored at 1oCto 6oC.
o Pigtail
Post Donation Instructions
• Most blood centers have a designated post donation area
where donors can sit and replenish their fluids.
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 WEEK 10: DONOR SCREENING
Hematomas
• A hematoma is a localized collection of extravasated blood
under the skin, resulting in a bluish discoloration.
Donor Recommendations • It is caused by the needle going through the vein, with
Please read the following instructions and sign at the bottom. subsequent leakage of blood.
1. Contact the blood center: • If a hematoma develops, the following instructions
• If any illness arises after your donation. apply:
• If you develop a headache and fever of 101 oF or higher within 1. Remove the tourniquet and needle from donor’s arm
14 days following your donation or if you become diagnosed 2. Apply pressure with sterile gauze pads for 7 to 10
with West Nile Virus infection. minutes, with the donor raising his or her arm above the
• If you have any questions about your donation or if you heart
remember something about your medical or personal history 3. Apply ice to the area for 5 minutes
that may affect your blood donation.
2. Do not smoke for one-half hour. Donor Bleeding
3. Eat and drink something before leaving. • Needle Insertion: 45 degrees angle then reduce to 10-20
4. Do not leave until released by the donor technician. degrees angle
5. Drink more fluids (nonalcoholic) than usual in the next four • Time allocation for Procedure: ≤15 MINUTES (less than or
hours, especially fruit juices. equal to 15 minutes)
6. Leave the bandage on for a few hours, and then you may
remove it. If there is any bleeding from the puncture site, raise Donor Records
arm, and apply direct pressure. • Donor records must be retained by the blood collection
7. If you feel faint or dizzy, either lie down or sit down with head facility as mandated by the FDA and AABB.
between the knees. • The minimum retention time for donor records varies from
8. Do not perform strenuous activities or engage in critical work 5 to 10 years to indefinite retention.
where safety requires your maximum abilities.
9. If any symptoms persist, either return to blood center or see RETENTION OF DONOR RECORDS
your doctor. Donor Record Retention Time
(years)
Donor ABO/Rh 10
Donor antibody screen 10
Informed consent for donation 10
Medical director approval for 5
donation interval
Physical examination 10
Medical history information 10
Identification number of donor unit 10
Viral marker testing results 10
Quarantine of donor unit 10
Repeat testing of donor blood 5
ID of donor processing tech 10
FIGURE 11–9 Post donation instructions. Plt count for frequent platelet 5
pheresis
Donor Reactions Sedimenting agent of leukopheresis 5
• Mild Reactions Notification of abnormal results 10/indefinite
• Moderate reactions Reference: Modified from AABB Standards, American
• Severe reactions Association of Blood Banks, Bethesda, MO 2002, p. 32.

Mild Reactions Donor Processing

• Syncope or fainting, nausea or vomiting, • The donor unit collected must be tested and processed by
hyperventilation, twitching, and muscle spasm. blood bank technologists before it can be made available for
• The following instructions apply for a donor who has transfusion.
fainted: • The tests performed on donor blood include the
1. Remove the tourniquet and withdraw needle following:
2. Place cold compresses on the donor’s forehead o ABO/Rh (include forward and reverse typing)
3. Raise the donor’s legs above the level of the head ▪ RH - anti-D reagent
4. Loosen tight clothing and secure airway ✓ Weak D - we used AHG phase testing
5. Monitor vital signs o Antibody Screen
• If the donor starts to feel nauseated or starts to vomit, ▪ IF POSITIVE WITH CLINICALLY SIGNIFICANT
the following instructions apply: ANTIBODY
1. Instruct the donor to breathe slowly ✓ When clinically significant antibodies were
2. Apply cold compresses to the forehead identified in the donor, FFP cannot be
3. Turn the donor’s head to one side and provide an prepared but we can still prepared platelet
appropriate receptacle concentrate and cryoprecipitate.
4. The donor may be given water after vomiting has ceased ▪ Although platelet concentrate and cryoprecipitate
contains a small amount of plasma, it does not
Moderate Reactions have antibodies.
• In addition to Mild reaction signs and symptoms, loss of ✓ Cryoprecipitate does not require
consciousness is a sign of Moderate reactions. compatibility testing, just specific typing.
• Decreased pulse rate, hyperventilation, fall in systolic ▪ Remember!!! Cryoprecipitate, fresh frozen plasma
pressure to 60mmHg. (FFP), platelet concentrate does not undergo
• The following instructions apply: cross-matching or compatibility testing. Only the
1. Check vital signs frequently specific typing is done in these processes.
2. Administer 95 percent oxygen and 5 percent carbon o HBsAg
dioxide o Anti-HBc
o Anti-HCV
Severe Reactions o Anti-HIV 1/2
o WNV RNA
• The presence of convulsions exhibited by the donor
▪ West Nile Virus RNA
defines severe reactions.
o Anti-HTLV I/II
• Convulsions can be caused by cerebral ischemia, marked
▪ anti- human T-cell lymphotrophic virus type I or
hyperventilation, or epilepsy.
II)
• The following should be followed by the donor room o Serologic test for syphilis
personnel:
▪ RPR (rapid plasma reagin) test
1. Call for help immediately; notify blood bank physician
2. Try and restrain the donor to prevent injury to self or
others
3. Ensure an adequate airway
• In the event of cardiac or respiratory difficulties, the donor
room staff should perform CPR until medical help arrives.

Nicole Anne Mamorno Page 5 of 7

 WEEK 10: DONOR SCREENING
ADDITIONAL INFO FROM THE BOOK
(you can skip this part or you can just read it!) 😊
DONOR PROCESSING:
Tests performed on donor blood
ABO/Rh
• Testing for the donor’s ABO group must include both forward
and reverse grouping.
o The 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 Rh type of the donor should be determined by testing
with anti-D reagent at the immediate spin phase.
o In the event the initial testing is negative, a test for weak
D should be performed. This involves a 37oC incubation
and an antihuman globulin (AHG) phase.
o If both the immediate spin and test for weak D are
negative, label the donor as Rh-negative; if, however,
any part of the testing yields a positive test for D, the
donor unit should be labeled as Rh-positive.
Antibody Screen
• AABB Standards requires that donors with a history of
pregnancy or transfusion be tested for unexpected
antibodies to RBC antigens.
• In the case of donors, a pooled screening cell is usually
tested against donor serum or plasma.
• The pooled screening cell contains antigens directed toward
significant alloantibodies.
• A control system must be in place for the method used. For
example, in the tube system, cells sensitized with IgG are
added to all negative tubes after the AHG phase; if the Gel
system is used, the blood center must follow the
manufacturer’s guidelines.
• Most blood centers choose to perform a test for unexpected
antibodies on all donors, not just those with a history of
pregnancy or transfusion.
• The introduction of automated instruments for donor
processing has helped to lessen the tedious workload of
ABO/Rh and antibody screens on donors. See the later
section on automation.
HBsAg
• The test procedure used must be one approved by the
FDA58 or a documented equivalent method. The methods
currently approved are the radioimmunoassay (RIA),
enzyme-linked immunosorbent assay (ELISA), and reverse
passive hemagglutination (RPHA). Of the three, the ELISA is
the most common procedure used. In this method, serum or
plasma is incubated with antigen to HBsAg. An enzyme-
conjugate mixture is added, and if the antibody is specific to
the antigen, a color change develops and can be quantified
spectrophotometrically.
• If the ELISA yields negative results, no further testing is
warranted; however, in the case of reactive results, the
screening test must be repeated in duplicate, and a positive
result is one in which one or both of the repeated tests are
positive. All components must be discarded when results are
positive.
• A supplemental test for HBsAg is neutralization.59 In this
method, the donor specimen is reacted with serum known to
contain antibody to HBsAg. If the positive reaction dissipates
upon incubation by at least 50 percent, the original screening
result is confirmed as a true positive as long as controls work
as expected.
• In the event the donor unit is needed in an emergency that
precludes completion of viral marker testing, a notation
indicating testing is not yet completed must be conspicuously
attached to the unit. If positive tests are found, the transfusion
service must be notified as soon as possible.
Anti-HBc
• Antibody to the core or interior protein on the hepatitis B virus
has been implicated in hepatitis C disease. This test was
once part of surrogate testing, along with its counterpart
alanine transferase (ALT).
• In 1995 a National Institutes of Health consensus panel voted
to discontinue the ALT test for blood donors because of the
increased sophistication and sensitivity for anti-HCV testing;
however, testing for anti-HBc has remained a requirement of
blood donors in the prevention of post-transfusion hepatitis
B. The methods employed are similar to those for HBsAg.
Anti-HCV and NAT
• The hepatitis C virus was identified in 198861 and was
initially referred to as non-A, non-B hepatitis.
Nicole Anne Mamorno
• Screening tests for anti-HCV involve enzyme immunoassay
(EIA) methods whose sensitivity has increased through three
generations of screening kits.
• Current assays detect antibodies to c200, c22–3, and NS-5
proteins of the HCV genome.
• In 1999 NAT for HCV RNA was implemented as a donor
screening assay under FDA-sanctioned Investigational New
Drug applications.
• NAT is 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.
• The window period for detection of HCV is reduced by
approximately 70 percent, from a mean of 82 days to 25
days.
• Confirmatory methods include the RIBA (recombinant
immunoblot assay).
• In this assay, fusion of HCV antigens to human superoxide
dismutase and a recombinant superoxide dismutase is
incorporated to detect nonspecific reactions.
• The test is reported as positive, negative, or indeterminate.
An individual who is positive by RIBA is considered to have
the HCV antibody.
Anti-HIV-1/2 and NAT
• All donor units must be screened for the presence of the HIV
1/2 antibody using an FDA-approved EIA method. If the initial
screening test is negative, the unit is suitable for transfusion;
if it is positive, the test must be repeated in duplicate. If any
one of the duplicate tests is reactive, the unit must be
discarded as well as any in-date components from prior
donations.
• Confirmation tests for HIV include the Western blot (Wb) and
the immunofluorescence assay (IFA).
• The Wb is performed using donor serum. HIV virus material
is separated into bands according to their molecular weight.
Material is transferred to a nitrocellulose membrane, and
donor serum is added. If antibodies to HIV are present, they
will bind to specific bands. Results are expressed as positive,
negative, or indeterminate.
• In the IFA technique, cells infected with HIV are fixed onto a
slide. Donor serum is added and incubated with the fixed
cells. If the donor serum contains antibody to HIV, the
antibody will bind to corresponding antigen on the cells. A
fluorescent labeled anti-IgG is added, and reactivity is
determined using a fluorescent microscope.
• HIV-1 testing for blood donations began in 1999 and has
effectively reduced the window period from 16 to 10 days.
This test has replaced the HIV-1 Ag test once required by the
AABB and FDA. Testing is done in pools of 16 or on an
individual basis.
WNV RNA
• As previously discussed, outbreaks of WNV in the United
States prompted donor testing for antibodies to WNV and, in
2003, NAT testing to detect RNA to the virus.
• Donor units are screened in pools of 6 or 16, and if the pool
is reactive individual units are tested.
• The Procleix WNV assay (Gen-Probe Inc) is a NAT test
currently available in the United States under the FDA
investigational New Drug Guidelines.
Anti-HTLV-I/II
• The HTLV-I virus or human T-cell lymphotrophic virus type I
is the causative agent of adult T-cell leukemia and has been
associated with a neurologic disorder called HTLV-
associated myelopathy. HTLV-II has been shown to have
about 60 percent homology with type I and is prevalent
among intravenous drug users in the United States. Persons
can contract both viruses from transfusion via infected
lymphocytes. Screening for HTLV-I began in 1988; a
combined HTLV-I/II was approved 10 years later in 1998.
This is an EIA screening test that utilizes viral lysates from
both viruses.
• As with the other viral markers, a donation that is repeatedly
reactive with EIA may not be used for transfusion. It is
recommended that if another EIA kit is used by another
manufacturer and that test is also positive, the donor should
be indefinitely deferred.66 Confirmatory tests include
Western blot, RIPA, and NAT testing.
Syphilis
• A serologic test for syphilis is required by both the AABB and
FDA. Screening tests include the rapid plasma reagin and
the Venereal Disease Research Laboratory. Both tests are
based on reagin, or antibody directed toward cardiolipin
particles. Cardiolipin-like antibodies have been documented
in persons with untreated infections from syphilis. Antibody
will agglutinate cardiolipin carbon particles in the form of
visible flocculation.
Page 6 of 7
 WEEK 10: DONOR SCREENING
• The confirmatory test for syphilis is the FTA-ABS or
fluorescent treponemal antibody absorption test. In this test,
indirect immunofluorescence is used to detect antibodies to
the spirochete T. pallidum, the agent that causes syphilis.
• There have never been any documented cases of
transfusion-transmitted syphilis. The spirochete that causes
syphilis, T. pallidum, cannot survive more than 72 hours in
citrated blood stored at 1o to 6oC, which would make platelets
the only component capable of transmitting infection.
• A serologic test for syphilis is also done because the disease
is characterized as being sexually transmitted and places the
donor at higher risk for possible exposure to hepatitis and
HIV.

Nicole Anne Mamorno Page 7 of 7