BLOOD COLLECTION:
Donor Screening, Collection, and Processing
I.
Introduction to Donor Selection
A.
Introduction
1.
2.
3.
4.
B.
Blood donor centers and transfusion services are responsible for
providing adequate blood supplies to meet the public demand.
The process begins with educating the public of the need
followed by the recruitment of appropriate donors. – The U.S.
blood supply depends upon volunteer blood donations.
Safety depends on a thorough screening of potential donors
and then appropriate processing of the units.
Every donor center must have detailed Standard Operating
Procedure (SOP) manuals that cover all phases of donor
activity.
Types of Donations
1.
2.
Several types of donations are routinely undertaken.
Allogeneic donation
a)
b)
3.
This is the most common type of donation.
An individual donates a unit of blood that can be used for
anyone having a compatible blood type with the donor.
Directed donation
a)
In this case, an individual donates a unit of blood that is only
to be used for a specific person.
(1)
(2)
4.
For example, members of a family with the same
blood type as a patient may donate blood and
“direct” that it only be used for the specified patient.
Blood donation centers and regulatory agencies frown
upon the use of directed donations, except for specific
purposes, since generally they have not been proven
to be safer than allogeneic donations.
Autologous donation
a)
When an individual is going to have a surgical procedure
performed that may require a transfusion, they may donate
1
b)
c)
5.
C.
their own blood for use during the surgery. - The blood is
labeled for their use only.
This is known as an autologous donation and requires
the consent of the patient’s doctor.
It has the advantage of not exposing the patient to
any potential transfusion-transmitted diseases.
In the following sections, we will be discussing the requirements for
allogeneic and directed donors. – Requirements for autologous
donations will be discussed at the end of this session.
Purpose of Selection Process
1.
2.
3.
The selection process is designed to protect both the donor and
potential recipient of the blood.
Just as patient confidentiality is important, donor
confidentiality must also be maintained.
Guidelines for donor qualifications are established by several
agencies.
a)
The Food and Drug Administration (FDA) is the ultimate
authority of regulations affecting blood centers since they
are responsible for licensing these organizations. – Donor
centers cannot ship blood across state lines without an
FDA license to operate.
(1)
(2)
(3)
b)
The FDA has established regulatory standards
that must be followed.
Licensed facilities undergo site visits (inspections) by
the FDA periodically to ensure they are meeting the
standards.
Failure of a donor center to follow the FDA
regulations and pass inspections may result in loss of
their license.
The AABB also plays an important role in the operation of
donor center.
(1)
(2)
Many donor centers seek accreditation by the
AABB.
Accreditation is a voluntary process by which a
facility decides to meet the standards established by
the accrediting agency. – Donor centers are not
required to be accredited by AABB in order to
operate but most seek this “seal of approval”.
2
(3)
(4)
Like the FDA, the AABB will visit accredited
donor centers periodically.
A word about AABB
(a)
(b)
(c)
c)
d)
AABB was originally known as the American
Association of Blood Banks, hence the
initials.
As the association expanded their scope to
accredit international facilities it was felt that a
new designation for the organization was
needed.
Since the acronym AABB was so widely
recognized, they decided to keep AABB but
stop using the words American Association of
Blood Banks.
In establishing the regulations for donors, these agencies
attempt to balance protection for the donors and recipients
while trying not to discourage voluntary donation.
Each donor center must develop SOPs that will meet the
requirements of both regulatory agencies if they are
licensed by the FDA and accredited by the AABB.
(1)
Note: Occasionally, a blood center may put in place a
slightly more stringent version of a FDA or AABB
regulation/guideline at the direction of the center’s
medical director. It is important to keep in mind that
all donor centers must adhere to the minimum
standards established by the FDA.
D. Process
1.
2.
3.
The donor selection or screening process includes three stages:
registration, medical history, and a physical examination.
Based on the information gathered from this process, the donor will
be found to be acceptable or not acceptable.
Donors not accepted are said to be “deferred”. – A donor may be
permanently deferred, temporarily deferred, or indefinitely deferred.
a)
b)
Someone who is permanently deferred will never be able
to donate blood for someone else. – They may be eligible
to donate autologous blood.
A prospective donor who is indefinitely deferred cannot
donate blood for someone else for an unspecified time due
to current regulatory requirements. (If the requirement
3
c)
4.
II.
changes in the future, they may be able to donate.) – They
may be eligible to donate autologous blood.
A donor who is temporarily deferred may donate at a future
time if he/she meets all of the donor criteria.
We will examine the donor selection process in detail in the next
sections.
Registration
A.
General Comments
1.
2.
3.
4.
B.
The information obtained during the registration process makes it
possible to notify, identify, and if necessary contact the donor.
Current information must be obtained at each donation. – In other
words, even if the donor has donated before, this information must
be collected again.
A system that allows the center to fully identify the donor and link
the donor to any existing records must be in place.
Records concerning donors and donations must be kept
indefinitely.
Required Demographic Information
1.
2.
3.
4.
5.
6.
Date and time of donation
Name: Last, first, and middle initial
Address: Residence and/or business
Telephone: Residence and/or business
Gender
Age or date of birth
a)
Donors must be ≥ 16 years old or conform to state law.
(1)
b)
7.
Note: Donors who are less than 17 years old are often
considered minors under the law in many states. – In
some states, 16 year olds may donate if written
consent from a parent or guardian has been obtained
in accordance with applicable state laws.
There is no maximum age limit. – The donor must be in good
health.
Identification such as a social security number or driver’s license
number. – This is usually necessary when using computer
retrieval systems.
4
C.
Useful Additional Information
1.
The individual blood center determines whether any of this
additional information is collected.
a)
b)
c)
III.
Race – Knowledge of race may be useful when screening for
specific blood phenotypes; however, it is imperative that the
donor understands the reason for asking this (i.e., medical
and scientific applications).
Unique characteristics of the donor – It may be useful to
know if the donor is CMV seronegative or has any previously
identified atypical antibodies.
If blood is directed for specific patient use (autologous or
directed donations), appropriate information about the
recipient is needed.
Medical History
A.
General Comments
1.
Prior to the commencement of the screening process, the donor
must be given educational materials describing:
a)
b)
c)
d)
2.
3.
4.
5.
6.
risks of the procedure
clinical signs/symptoms associated with HIV infection
behavioral risk factors that may lead to transmission of
blood-borne pathogens
importance of refraining from donating if they are at
increased risk of being infected
After reading the educational materials, they should be given the
opportunity to ask questions before proceeding to the medical
history.
The medical history is used to identify potential risk factors that
could jeopardize the health of the donor or the recipient.
In the past, a donor center developed their own questionnaire
based on current requirements. – Currently, a standardized
questionnaire has been introduced by the AABB that is more userfriendly than previous questionnaires. (See your textbook for the
questionnaire.)
Most facilities have the donor respond to the questionnaire in
writing or through use of a computer.
Any questions arising from the donor’s responses are then followed
up in an interview.
5
7.
8.
9.
B.
Doubtful or unclear answers to questions about illnesses should be
referred to the blood bank medical director.
It is important to remember that the donor history questionnaire and
acceptance or deferral criteria change quite frequently as new
infectious diseases emerge and scientific information about these
infections becomes available.
A donor center must have SOPs written with the most current
regulations in effect.
Questions and Rationale
1.
Questions designed to assess the current health of the donor are
asked.
a) Examples
(1)
(2)
b)
c)
Feeling healthy and well today?
Taking antibiotics or other medications?
It is important to know if the donor is ill or has had a recent
infection. – Many blood centers impose a one month deferral
following a viral or bacterial infection.
Ingestion of certain medications may require a temporary
deferral or permanent deferral.
(1)
(2)
(3)
Most drugs are acceptable.
Deferrals for drugs are often based on the nature of
the disease process for which they are prescribed.
Examples of deferrals
(a)
(b)
(c)
Accutane, Proscar, Propecia – one month
Antimalarial drugs - 1 year
Human pituitary-derived growth hormone
(HGH) – permanent (Recombinant forms of
growth hormone are acceptable)
(i)
(d)
Human growth hormone derived from
human pituitary glands has been
associated with Creutzfeldt-Jakob
disease, a disease transmitted by prions
and resulting in disease of the central
nervous system (presenile dementia).
Tegison (psoriasis) – permanent deferral
6
(e)
(f)
(g)
(4)
2.
Bovine insulin manufactured in the UK
– indefinite deferral
Hepatitis B immune globulin given after
suspected exposure to contaminated body
fluids – 12 month deferral
Aspirin or aspirin-containing products - 2 days
if the donor is to be the source of single-donor
platelets. Aspirin prevents platelet
aggregation.
The donor center should have a current list of drugs in
their SOP manuals that will result in deferral. – This
medication list should be provided to the donor for
review if taking any medications, so they may
inform the interviewer which medication they are
taking.
Questions to assess surgeries, pregnancies, transfusions,
transplants, inoculations, or other piercings of body tissues
a) Examples
(1)
Are you pregnant or been pregnant in the past 6
weeks?
(a)
(2)
Donated blood in past 8 weeks?
(a)
(b)
(3)
Defer if “yes” – can donate 6 weeks after
pregnancy if she has fully recovered
There should be 8 weeks between donation
of a unit of whole blood, except under special
circumstances.
Special time periods apply to donations by
apheresis.
Had any vaccinations or shots?
(a)
(b)
Recently immunized donors are usually
acceptable if they received toxoid or killed
vaccines and are symptom-free.
Vaccinations with live attenuated vaccines may
vary. - Examples of deferrals
(i)
(ii)
7
Rabies vaccine - 1 year
Measles (rubeola), mumps, polio (oral) 2 weeks
(iii)
(4)
Transfusions in past 12 months?
(a)
(b)
(5)
Deferrals vary with the type of transplant and
relate to risks of disease transmission with the
transplanted tissue/organ.
Had a tattoo or other type of body piercing in past 12
months?
(a)
3.
Transfusions of whole blood and
blood components – defer 12 months
Surgery - defer at least 12 months if they
received blood or components; if surgery is
uncomplicated and did not require
transfusion, they may donate.
Had a transplant of an organ or other tissues in past
12 months?
(a)
(6)
Rubella (German measles) and
chicken pox (varicella zoster) - 4 weeks
Someone who has had a tattoo or any other
skin piercing where sterility of the needle
cannot be verified is deferred 12 months.
Questions related to overall health of the donor
a) Examples
(1)
(2)
(3)
b)
c)
d)
Had any type of cancer, including leukemia?
Had any problems with your heart or lungs?
Had a bleeding condition or a blood disease?
Someone with a history of chronic heart disease (CHD) with
known residual damage should be deferred unless evaluated
and approved by a physician.
Active pulmonary disease - defer; treated tuberculosis (TB),
symptom-free asthma donors are okay
Other than localized skin cancer, a physician usually must
evaluate individual cases.
(1)
Many centers permit donors with a previous history of
cancer, but free of disease for five years to donate.
8
e)
f)
4.
History of leukemia or lymphoma – traditionally a permanent
deferral although a few blood centers have been allowing
individuals with a history of childhood leukemia who have
been disease-free for five or more years to donate
Bleeding diseases - need evaluation by a physician
Questions related to donor exposure to infectious diseases
a)
Questions related to travel
(1)
(2)
Questions are asked to determine whether the
individual may have been exposed to malaria, HIV
group O, variant Creutzfeld-Jakob disease,
Leishmania, and SARS.
Malaria
(a)
(b)
(c)
(d)
Travelers to endemic areas - defer for 1 year
after return
Someone who has taken antimalarial
prophylaxis – defer for 1 year after stopping the
drug
Someone who has had malaria - 3 years after
cessation of symptoms
Residents or immigrants from endemic areas
for malaria – defer 3 years (a recent list of
endemic areas should be available, preferably
in the SOP manual)
(3)
Anyone diagnosed with babesiosis or Chagas disease
(Trypanosoma cruzi) – indefinite deferral
b)
Other travel-related deferrals
(1)
(2)
(3)
c)
d)
Leishmaniasis – AABB current guideline is to defer for
12 months from date of departure donors who have
been to Iraq
Anyone who spent up to three months or more from
1980-1996 in the United Kingdom or five or more
years (1980-present) in Europe – defer indefinitely for
risk of vCJD
Zika, Dengue, and Chikungunya Viruses- defer for 28
days after returning from outbreak areas.
West Nile Virus (WNV) – diagnosed case deferred for 120
days
Questions related to HIV, HTLV and hepatitis
9
(1)
Permanently defer
(a)
(b)
(c)
(d)
(e)
(f)
(2)
12 month deferral examples
(a)
(b)
(c)
(d)
(3)
Persons having sexual contact with someone
with viral hepatitis or HIV/AIDS
Persons who have received Hepatitis B
immunoglobulin (HBIg)
Confirmed positive test for syphilis
Someone who has had male-to-male sex
Indefinite deferral for donors at risk for HIV group O
(a)
(b)
IV.
Someone with a history of viral hepatitis after
their 11th birthday – persons who were told
they had jaundice as a baby/child are generally
acceptable unless there is documentation of
viral hepatitis
Donor with a positive test for hepatitis
(HBV and/or HCV)
Anyone with unexplained jaundice or
cirrhosis of the liver
Someone with a diagnosis of HIV/AIDS
Positive test for HIV, HTLV
Someone who has used self-injected
nonprescription drugs
Person who had sexual contact with
someone who was born or lived in Africa
Questions designed to identify donors at risk
for HIV group O infection can be deleted from
donor questionnaires if the lab uses an HIV
antibody test approved by the FDA that
claims to detect HIV group O
Physical Examination
A.
General Appearance
1.
If the donor looks ill, appears under the influence of drugs or
alcohol, or appears excessively nervous, it is best to defer.
10
a)
B.
Hemoglobin or Hematocrit
1.
2.
3.
4.
The hemoglobin (Hgb) or hematocrit (Hct) is checked to
prevent taking blood from someone who is anemic.
Capillary blood for testing is usually obtained by fingerstick.
Many qualitative and quantitative methods and instruments are
available.
One of the common hemoglobin screening method employs
copper sulfate.
a)
b)
c)
d)
e)
Blood dropped into
copper sulfate
5.
The density of a drop of blood is proportional to the amount
of hemoglobin present in the cell.
A solution of copper sulfate having a specific gravity of
1.053 is placed in a container.
A drop of the donor’s fingerstick blood is allowed to drop
into the solution.
If the drop of blood is denser than the copper sulfate
solution (i.e. contains hemoglobin equal to or greater than
the minimum acceptable level), it will fall to the bottom of the
container within 15 seconds.
If the blood fails to drop, a quantitative method should be
used to verify the results.
Blood drop floats
on top then...
Falls to bottom
within 15 seconds:
ACCEPTABLE
If drop fails to fall to bottom
within 15 seconds:
UNACCEPTABLE
If quantitative methods are used the following limits must be met.
a)
Allogeneic donor: Female Hgb - >12.5 g/dl; Hct - >38%
Male Hgb- >13.0 g/dl; Hct - >39%
**Females may be able to donate with a Hgb- >12.0 g/dl; Hct
- >36% if additional steps are taken to assure their safety.
b)
C.
Try not to antagonize the donor and encourage them to
donate at a future time.
Autologous donor: Hgb - >11 g/dl; Hct - >33%
Blood Pressure
1.
The systolic pressure should be between 90 and 180 mm Hg;
diastolic pressure should be between 50 and 100 mm Hg.
2.
D.
If elevated, the donor should rest 5-10 minutes and retake. Temporarily defer the donor if it is still elevated and suggest they see
a physician.
Pulse
1.
2.
Acceptable: 50-100 beats per minute with no irregularities
A lower rate may be acceptable if the patient reveals a history of
intensive exercise (Ex. marathon runners) and is otherwise in good
health.
E. Temperature
1.
2.
3.
Purpose: To detect evidence of illness
Temperature is usually taken orally and should not exceed 99.5oF (37.5oC).
A lower than normal temperature is usually not significant in a
healthy person but should be repeated.
F. Weight
1.
2.
A donor weighing 110 lbs (50kg) may give 450 ± 10% (405-495 mL)
if using a 450 mL collection bag, or 500 ± 10% (450-550 mL) if using a
500 mL collection bag.
Donors weighing less may be drawn but no more than 10.5 mL/kg
may be removed including the approximately 30 mL of samples for
testing.
a)
b)
c)
d)
If less than 405 mL is drawn, the unit must be labeled as a low
volume (300-404 mL) unit and only used for preparation of red
blood cells.
The plasma from low volume units cannot be transfused because
the abnormal anticoagulant/plasma ratio.
A blood donor center may not wish to be troubled by these low
volume units and may reject a donor weighing less than 110 lbs.
Local SOPs will dictate blood collection procedures at donor
centers.
12
Physical Examination (Allogeneic Donation)
Requirement
Procedure
Hemoglobin
>12.5 g/dl females 13.0 g/dl for males
Hematocrit
> 38% females >39% for males
Blood Pressure
Systolic: 90-180 mm Hg
Diastolic: 50-100 mm Hg
50-100 beats/min
≤ 99.5oF (37.5oC)
> 110 lbs
Pulse
Temperature
Weight
G.
Skin Lesions
1.
2.
V.
General Comments on Donor Records
A.
Donor Records
1.
2.
B.
Donor records must contain the interviewer’s initials, signature,
and/or code.
Reasons for deferral must be recorded and explained to the donor.
Abnor m alit ie s
1.
2.
3.
VI.
The skin at the site of venipuncture must be free of lesions.
Mild skin disorders such as acne or psoriasis should not be
deferred unless the donor is taking Accutane or Tegison, or if the
rash is extensive and in the antecubital region.
A mechanism must exist for informing a donor of
significant abnormalities.
This may be done verbally by qualified personnel if it occurs during
the screening phase.
Abnormalities detected in post-donation testing may be reported by
telephone or letter by qualified personnel following the facility’s
SOP.
Informed Consent (Statement of Understanding)
A.
Informed Consent
1.
2.
3.
4.
5.
6.
Prior to donating, donors should be informed of testing to be done
on their blood and to whom abnormal results will be reported.
They should be made aware that recipients are at risk of acquiring
infections from blood and that blood can test negative early in
infection especially with some viruses.
The interviewer must explain all steps and processes in terms that
the donor can understand before the donor is asked to sign the
consent form.
Donors must acknowledge they have been told about the process,
risks, etc. and given written information about AIDS (high-risk
behaviors, damage to others).
They must agree they have had a chance to ask questions and
understand what has been told them.
Signed consent forms attest that they have read and understood
what has been said or what they have read.
VII. Phlebotomy
A.
Bag Selection
1.
2.
3.
Blood is collected using sterile, closed systems by qualified
personnel. – Collection must take place in FDA-approved
containers (bags).
The type of bag chosen to receive the blood depends upon the
preference of the donor center and the planned use of the blood.
A primary bag containing an anticoagulant receives the blood from
the patient.
Plastic
tubing
Primary
collection bag
containing
anticoagulant
Needle
14
4. Satellite bags are attached to the primary bag for the preparation of
various blood components. There may also be a bag with Additive
Solution (AS) for the Red Blood Cells (RBCs).
Plastic
tubing
Primary
collection bag
containing
anticoagulant
Satellite
bag #1
Satellite
bag #2
Needle
B.
Identification
1.
A unique identification number with an accompanying bar code
must be placed on the primary unit, attached bags, pilot tubes, and
donor registration form.
a)
C.
Arm preparation, Phlebotomy and Blood Collection
1.
D.
Read the sections in your text that describe these procedures.
Care of the Donor
1.
2.
3.
E.
Pilot tubes are tubes that are filled with donor blood that will
be used to test for evidence of transfusion-associated
infectious diseases and all other required tests.
Donors should never be left alone after completion of the blood
collection since they may experience reactions.
Normally, the donor is given something to drink (Ex. orange juice)
after the phlebotomy is completed.
The donor should be closely watched for signs of a reaction.
Donor Reactions
15
1.
General Comments
a)
b)
2.
Grade I Reactions
a)
b)
c)
3.
These reactions are mild and mostly related to psychological
factors such as apprehension, emotional stress, and the
sight of blood.
Symptoms include pallor, weakness, sweating, perspiration,
rapid breathing, dizziness, and/or nausea.
If these symptoms are severe, the collection may have to be
terminated.
Grade II Reactions
a)
b)
c)
d)
e)
4.
Most donors tolerate the procedure without problems.
Studies show first-time donors, those with an elevated pulse
rate, or low diastolic or high systolic pressure are more likely
to experience a reaction.
These are moderately severe reactions.
Donors may experience all of the signs and symptoms of a
grade I reaction plus fainting.
The collection must be discontinued immediately.
The donor’s symptoms should be treated by raising their feet
above their head if possible and administering ammonia by
inhalation.
The blood pressure, pulse, and respiration rate should be
monitored until the donor recovers.
Grade III Reactions
a)
b)
c)
d)
Grade III reactions are severe.
These reactions are characterized by any or all of the grade
II symptoms along with any or all of following: involuntary
muscle contractions, suspended respiration, cyanosis, or
convulsions.
The needle must be removed immediately if these symptoms
appear.
The phlebotomist must make certain the donor’s airway is
open and must contact a physician as soon as possible.
VIII. Donor Unit Processing
A. Comments
16
1.
2.
3.
B.
Once the donor unit has been obtained, it must undergo
extensive testing before it can be used for transfusion purposes.
The FDA dictates the required testing of donated blood.
These tests include testing for a wide range of infectious diseases
as well as tests to determine the blood group of the unit. – Required
testing for infectious diseases changes as the needs demand.
Required Testing
1.
ABO and Rh blood grouping
a)
2.
Antibody screen
a)
b)
3.
Determination of the ABO blood group must include front
and back typing. – We will see what this means in a future
session.
Antibody screening tests are performed to identify
donors with unexpected antibodies in their plasma.
If the blood tests positive, the donor blood can only be
processed into red cells with a minimum of plasma left in the
unit.
Serologic test for syphilis
a)
Although transmission of syphilis from blood products is
highly unlikely, testing for syphilis has remained as a marker
of sexually- transmitted diseases.
(1)
b)
4.
A donor who tests positive for syphilis may be at a
greater risk for transmission of other sexually
transmitted diseases, such as HIV and hepatitis.
The standard test is the RPR, but other tests (i.e.,
microhemagglutination, EIA), may be used in
large, automated processing centers.
Hepatitis Testing
a)
b)
Tests for hepatitis B and C must be performed: HBsAg, antiHBc, anti-HCV, HBV-Nucleic Acid Testing (NAT), and HCVNAT.
Enzyme immunoassays (EIA/ELISA) are most commonly
used to detect HbsAg, anti-HBc and anti-HCV.
17
c)
d)
5.
Nucleic acid amplification testing (NAT) is used to detect the
viral nuclear material making it possible to detect the
presence of an infection during the so-called “window period”
after infection but before the person starts producing
antibodies. – NAT tests may be performed as an individual
test or in a combined HIV/HCV/HBV assay.
Positive EIA tests should be retested in duplicate and if
repeat positive must have a confirmatory test performed.
Human Immunodeficiency Virus (HIV) testing
a)
Tests for anti-HIV-1, anti-HIV-2, and HIV-NAT are required.
(1)
(2)
b)
c)
6.
Blood with a positive EIA screening test must be retested in
duplicate since false positives may occur.
Blood testing repeatedly positive with an EIA method is
tested with a supplemental test such as the Western blot.
Human T Lymphotropic Virus (HTLV-I/II) testing
a)
b)
HTLV is a virus that can be transmitted by cellular
products and lead to a form of leukemia.
An EIA antibody test for anti-HTLV-I is used to
detect evidence of viral infection.
(1)
(2)
(3)
7.
HTLV-II is a variant of the virus known as HTLV-I.
Because of cross-reactivity issues and the similarity of
the two viruses, screening tests for HTLV-I will also
detect HTLV-II.
Supplemental Western blot assays are performed if
tests are repeatedly positive.
West Nile Virus
a)
b)
8.
A combination EIA test for anti-HIV1/2 that detects
both antibodies may be used for screening purposes.
HIV-NAT may be performed as an individual assay or
a combined HIV/HCV/HBV assay may be used.
The virus is spread by the bite of an infected mosquito and
can infect humans, horses, birds, and some other animals.
Nucleic acid testing is currently used to screen blood.
Trypanosoma cruzi (T. cruzi)
18
a)
b)
c)
d)
e)
T. cruzi is a parasitic infection that causes Chagas disease.
It is most commonly seen in parts of Mexico, Central
and South America.
With the influx of immigrants from these countries into the
U.S., it has been recognized as a growing concern.
The first EIA screening test licensed by the FDA was
introduced in January 2007.
The FDA requires the testing of all donors at least once
but most donor centers test every donation.
Summary of Required Donor Unit Testing
ABO & Rh Grouping
Antibody Screen
Tests for:
Syphilis
HBsAg
Anti-HBc
Anti-HCV
HIV/HCV/HBV-NAT
Anti-HIV-1/2
Anti-HTLV-I/II
WNV-NAT
T.cruzi
Zika-NAT
9. Zika virus – a flavivirus, is transmitted by Aedes mosquitoes, most
commonly by A. aegypti. Of concern is the apparent epidemic of
microcephaly, a devastating neurodevelopmental abnormality in babies
born from mothers infected with the virus. Transmission is possible by
transfusion. FDA mandated testing of blood donors in 2016.
C.
Testing at a Receiving (Transfusion) Facility
1.
2.
3.
4.
Many transfusion services do not operate a donor center.
Even at those facilities that collect donor blood, rarely is
enough blood collected to meet all of the facility’s needs.
Therefore, blood is bought from collection centers such as
the American Red Cross/America’s Blood Centers.
Blood drawn elsewhere and sent to a transfusion service must
be tested to ensure the safety of the blood.
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5.
6.
7.
IX.
The receiving facility must confirm the ABO grouping and the
Rh on Rh negative units to ensure the units have not been
mislabeled.
Tests for infectious diseases are not repeated.
Antibody screens are not repeated since problems will most
likely be detected during pre-transfusion testing.
Special Donations
A.
Autologous Donation
1.
2.
3.
As noted earlier, when a person donates blood for
his/her own usage, this is known as an autologous
donation.
Autologous donations have been encouraged whenever
possible as a means of decreasing the likelihood of acquiring
a transfusion- associated disease.
Preoperative autologous donation requirements
a)
b)
c)
A patient’s physician counsels the patient about the
use of autologous donation prior to elective surgery.
The physician must notify the donor center of his
approval for the autologous donation.
Additionally, the patient must give written consent
for the procedure.
(1) Consent forms must explain the risks and benefits
of autologous donation.
d)
The patient should be encouraged to take s
supplemental iron.
(1) The physician frequently prescribes iron tablets to
boost blood production due to loss of iron during
phlebotomy.
e)
Fees
(1) There are costs associated with the collection,
processing, and storing of autologous blood.
(2) The patient must be informed about any costs
associated with this process.
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f)
Screening process
(1) While autologous collection shares many elements
in common with allogeneic donation, there are some
requirements that are different.
(2) Certain conditions are contraindications to
autologous donation.
Contraindications for Autologous Donation
Bacteremia
Acutely symptomatic angina
Recent seizures
Valvular heart lesions
MI or stroke within 6 months
Significant cardiac or pulmonary disease
Uncontrolled hypertension
(a)
Ultimately, the transfusion service’s medical
director in consultation with the patient’s
physician will determine whether the patient
may donate.
(3) Age
(a)
(b)
There is no upper age limit.
Determinations concerning children are based
on the child’s size and capacity to understand
and cooperate. – Parental consent is required.
(4) Weight
(a)
If the patient weighs less than 110 lbs, the
amount of blood drawn may be adjusted based
on his/her weight.
(5) Hematocrit/hemoglobin
(a)
The patient’s hematocrit should be 33% or
higher or the hemoglobin at least 11.0 g/dL.
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(b)
(6)
Donation schedule
(a)
(b)
(c)
(7)
The medical director may make exceptions in
consultation with the patient’s physician.
The donation schedule is established by the
donor center and its director with physician
input.
It may be once a week provided the patient has
an adequate hemoglobin/hematocrit.
The last donation must be more than 72 hours
prior to surgery. – It is preferable if it is
longer to allow for stabilization of the blood
count.
Required testing
(a)
(b)
(c)
ABO and Rh typing is required.
Antibody screens and crossmatching are not
required.
Tests for infectious diseases
(i)
(ii)
If the blood is drawn in the facility
where the blood will be transfused, the
facility is not required to test the blood
for infectious diseases.
If the blood is drawn at one facility and
will be shipped to another where the
transfusion will take place, tests for
infectious diseases must be performed.
(a) If a patient donates more thanone
unit in a 30-day period, the tests for
infectious diseases need only be
performed on the first unit.
(b) FDA and AABB requirements
state that the patient’s physician and the
patient must be informed of any
abnormal results.
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4.
Labeling of autologous blood
a)
b)
c)
d)
e)
5.
Storage
a)
b)
B.
Proper labeling is required to identify the blood
as “autologous” blood.
Patient information and identification of the drawing facility
(including FDA license or registration number) is required.
Units must be clearly labeled “For Autologous Use Only”,
and include the expiration date.
Unit labels should also contain the phrase “Donor untested”
or “Donor tested within the Last 30 days”.
If the unit tested positive for infectious diseases and will
be used, it must have a biohazard label attached. – The
receiving facility should be informed of the circumstances.
Autologous units must be kept segregated from the
allogeneic supply in refrigerators and freezers.
Most facilities will have separate, labeled refrigerators for
each type of blood supply.
Directed Donations
1.
2.
Donors making a directed donation must meet the same criteria as
allogeneic donors except that the blood is designated for use by a
specific patient.
Appropriateness of directed donations
a)
There are relatively few instances when directed donations
are appropriate.
(1)
Ex. Newborn with neonatal thrombocytopenia
(a)
b)
In these cases, the condition is best treated
with platelets from the mother.
Directed donations should be discouraged when a woman
of childbearing age desires to receive her husband’s blood
rather than that of a allogeneic donor. – Unless the wife and
husband have identical genetic characteristics, the potential
for development of alloantibodies that could affect future
pregnancies is highly likely.
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C.
Therapeutic Phlebotomy
1.
2.
As the name implies, this form of blood collection is performed to
relieve symptoms.
A specified amount of blood is drawn to decrease the red blood cell
mass in certain medical conditions.
a)
3.
4.
A patient’s physician must issue a written request for the
phlebotomy.
Blood collected is usually discarded.
a)
b)
D.
Examples of medical conditions: polycythemia vera, cyanotic
heart disease, hemochromatosis
There are rare instances when this blood may be used.
These instances are outlined in FDA and AABB regulations.
Apheresis (Hemapheresis)
1.
2.
3.
Apheresis is a special collection process in which a specific blood
component is removed and the remainder of the blood returned to
the donor or patient.
It is a technique most commonly used to collect large numbers of
platelets from a single donor.
Procedure
a) A donor is attached to a machine that separates the
component desired using flow centrifugation.
b) Blood removed from the donor passes through the instrument
that then uses centrifugal force to separate components by
densities.
c) The desired component is collected and the remainder of the
blood is returned to the patient.
4.
This technique can also be used for therapeutic purposes to
remove components. – Plateletpheresis (removal of platelets) is
the most common application. No more than 24 plateletpheresis
donations a year are allowed. Depending on the volume of
red cells not returned to the donor during apheresis, a donor
may donate whole blood 48 hours after an apheresis
collection.
5.
The most common anticoagulant used in apheresis is acid citrate
dextrose (ACD).
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