Test 6: Donor Selection and Testing Flashcards
the process of separating blood into its different components: Platelets, red blood cells (RBCs) and plasma.
apheresis
Whole blood is collected in a ratio of _____ mL anticoagulant per _____ mL whole blood.
14, 100
Collection ratios:
-450 mL whole blood with ____ mL anticoagulant-preservative
-500 mL whole blood with ___ mL anticoagulant-preservative
63, 70
*remember basic info, but do not need to calculate for exam.
Packed RBCs:
-AS (additive solution) = Hematocrit of _____ %
- No AS = Hematocrit of ____ %
55-65
65-80
Based on a 70 kg adult, one unit of packed RBCs will raise Hgb by how much?
1 gram (3% Hct)
What anticoagulant-preservative can be used for babies?
Citrate-phosphate-dextrose-adenine (CPDA-1)
-longer shelf life of 35 days (all others are 21 days)
What is the only Red blood cells additive solution that can be used for babies? Why?
AS-3 ((Nutricel)
-only one that does not contain mannitol (it harms babies brains)
What are the substances that help support red cell membrane?
SAGM
-saline
-adenine
-glucose
-mannitol
Why are additives used for Red blood cells?
they double the shelf life, good for 42 days
Plasma:
FFP must be frozen within ____ hours.
8
Plasma:
FFP can be frozen for up to _______.
Once thawed, ______ expiration.
1 year
24 hour
*same for PF24
FFP has maximum levels of…
both stable and labile clotting factors, about 1 international unit (IU) per milliliter
-factors 5 and 8
PF24 must be frozen within 24 hours. What is the disadvantage?
Slightly reduced levels of F VIII, then FFP
PF24RT24 – kept at room temp up to 24 hours, then frozen
Frozen for up to 1 year
Once thawed, _____ exp
5 day
LP (liquid plasma) – plasma from whole blood maintained at ____ C, ___ day exp
1-6
26
Thawed Plasma (TP) – Passed 24 hour thaw expiration, stored
for an additional ___ days (___ days total)
4, 5
What is the disadvantage of Thawed Plasma (TP)?
Can not maintain therapeutic levels of labile factors V and VIII
What is liquid plasma used for?
trauma cases, don’t need to wait to give to the patient.
LP (liquid plasma) can become what after expiration so it can still be used?
Thawed plasma (5 day exp)
What are the two different platelet product types?
-From whole blood = “Random Donor” = RDP (from 5-6 people to = one apheresis donor)
-Apheresis = “single Donor” = SDP (less risk of a reaction)
Around 6 RDP = 1 SDP to raise platelet count by ___________
30—60,000
Cryoprecipitated
Antihemophilic Factor aka…
Cryoprecipitated AHF, or Cryo
Cryo concentration of….
-factor VIII (AHF)
-fibrinogen
-factor XIII
-vWF (along
with ADAMTS13)
-cryoglobulin
-fibronectin
Preparation cryo : FFP thawed at 1-6oC, centrifuged cold hard spin, supernatant expressed, cryo refrozen within 1 hr
-Supernatant = _________
-Button = Cryoprecipitate
Cryo-poor plasma (CPP) —-> Plasma Cryoprecipitate
Reduced
1 unit Plasma yields 1 unit cryo (adult dose = 10 units cryo)
____ mg fibrinogen
____ units of AHF
150
80
Cryo:
-Pre-storage pool – once thawed, expire in ____hours at 20-24 C
-Post-storage pool – thawed then pooled, expire in ___ hours at 20-24 C
6
4
Leukoreduction:
Less than ________ WBC per whole blood, red blood cells, apheresis platelets
Less than _______ WBC per whole blood derived platelets
5.0 x 10^6
8.3 x 10^5
***must know these numbers!
Leukoreduction:
less than ____% recovery
85
The amount of blood that remains after reduction
Leukoreduction:
prestorage should be within ___ hours.
72
Leukoreduction:
Do all units have WBC counts performed?
No
_______ and ________ must go in the fridge after thawing.
red cells and plasma
True or false?
Apheresis blood and blood components do not need to be run through a LR filter.
true
Leukocyte Reduction:
-At patient bedside by inexperienced personnel
Filter must be perfectly _________
Blood cannot be forced through (no pumps)
Cannot flush filter
vertical
Leukocyte Reduction:
What are the types of additional manufacturing?
-Irradiation (cesium, cobalt, x-ray)
-Washing (allergic reactions, removal of antibody or other substances)
-Aliquots (can do in a closed system)
-pooling (cyro, plasma, platelets)
-Reconstituted Whole Blood
-Frozen, Deglycerolized RBCs
What are the types of Frozen, Deglycerolized RBCs?
- High Glycerol
- Low Glycerol
- QC – 80% recovery and less than 1% residual glycerol
What is the goal of leukoreduction?
effect on exp?
less than 5 million WBC per unit
none
What is the goal of washing?
affect on exp?
-IgA Deficiency
-Severe Anaphylactic Rxn
-Rejuvenation
-Removal of Glycerol
24 hours (open system)
What is the goal of Irradiation?
Effect on exp?
Inactivate residual
donor lymphocytes =
prevent GVHD
28 days post
irradiation, or
original expiration,
whichever is sooner
What is the affect on exp with freezing?
good for 10 years from collection
What is the blood components travelling temp?
1-10 degrees up to 24 hours at this temp
The Food and Drug
Administration (FDA)
establishes donor criteria
through the Code of….
Federal regulations
-Guidelines are written in the
Standards for Blood Banks and Transfusion Services (AABB)
_________ developed the donor history questionnaire
* Questionnaire meets FDA requirements
AABB
permanent deferral?
history of viral hepatitis after 11th birthday?
yes
permanent deferral?
positive for hep B surface antigen
yes
permanent deferral?
-reactive to antibodies to hep B core on more than one occasion
yes
permanent deferral?
past or present infection of hep C, Human T-cell lymphotropic virus, or HIV
yes
permanent deferral?
History of babesiosis or Chagas disease
yes
permanent deferral?
Family history of CJD
yes
permanent deferral?
Recipient of dura mater or human pituitary growth hormone
yes
permanent deferral?
Risk of vCJD
yes
permanent deferral?
Use of a needle to administer nonprescription drugs
yes
How many months must someone wait to donate if they get a tattoo, piecing, or pregnant.
3 months
Deferral for hep B vaccine?
NO!!!!**
What does the donor physical examination include?
-General appearance
* Weight
* Temperature
* Pulse
* Blood pressure
* Hemoglobin
* Skin lesions
What must hemoglobin be for donors?*
≥12.5 g/dL (125 g/L) Females
13.0 g/dL (130 g/L) Males
What must Hematocrit be for donors?*
≥38% Females
≥39% Males
What must blood pressure be for donors?*
Systolic 90–180 mm
Diastolic: 50–100 mm
What must temp be for donors?*
≤37.5° C (99.5° F)
What must the pulse be for donors?*
50–100 beats/minute
What is the min weight for donors?*
Minimum 110 lb (50 kg
What is the age requirement for donors?*
Conform to applicable state law or >16 years
What needle is used on donors?
16-gauge needle
Most autologous blood is used to treat…
surgical blood loss in very specific situations where there is a reasonable opportunity to avoid
homologous transfusions and/or when compatible allogeneic blood is not available.
How long is autologous blood kept for?
*must be kept till it expires!
Disadvantages of autologous donation/transfusion
beyond the usual risks…
-Bacterial contamination
* Circulatory overload
* Cytokine mediated reactions and product/recipient
misidentification
What are the 3 types of autologous donations?
-preoperative
-normovolemic
-blood recovery
Types of Autologous Donations:
Blood is drawn and
stored before the
anticipated date
* Certain criteria must
be met
preoperative
Types of Autologous Donations:
Removing units at the
beginning of surgery
and reinfusing them at the end of surgery
normovolemic
-blood volume stays the same (replaced with saline)
Types of Autologous Donations:
A medical device is
used to wash, filter,
and concentrate blood
during an operation
blood recovery aka blood salvage
Preoperative
Donation Criteria:
can donate up to ____ hours prior to surgery.
72
How is the Preoperative
Donation Criteria different?
-High-risk questions do not apply
* No age restriction
* If weight is less than 110 pounds, the volume is adjusted
* Hemoglobin is 11 g/dL or higher
* Hematocrit is 33% or higher
With directed donations, the 56-day interval may be
waived with…
a medical director’s approval
Components are separated, and the remaining blood is returned to the donor
Apheresis
Platelet count must be at least _______ for plateletpheresis.
150,000/μL
Plateletpheresis:
Donations are made at least ____ hours apart, no more than ___________ (or 24
times a year)
48
twice a week
How often can Plasmapheresis be done?
Infrequent: No more than once every 4 weeks
Frequent: Immunoglobulin G and M (IgG and IgM) levels are monitored every 4 months if donations are more than once every 4 weeks
How often can Red cell apheresis be done?
Two units of RBCs may be donated if weight and height requirements are met
Deferral is 16 weeks following double
RBC donation
What are the requirements for donor records?
Donor records must be retained by the blood
collection facility as mandated by the FDA and
AABB.
* There must be a system to ensure that confidentiality
of the donor is not compromised, and that donor records are not altered.
What is the likelihood of a transfusiontransmitted disease (TTD)?
very small, Blood components undergo
rigorous testing that makes
them extremely safe
However, bacterial, viral,
parasitic, and prion pathogens constantly evolve, and if not detected in the testing process, can cause harm and even death
Donor tests can be divided into what 2 categories?
-Immunohematologic
testing (ABO and D
testing and antibody
screen)
-Infectious disease
screening
What are the required hepatitis tests? ***
HBsAg
HBV DNA (NAT)
Anti-HBc
Anti-HCV
HCV NAT
What are disease tests that must be done on donor blood besides hepatitis tests?
HIV-1/2*
HTLV-I/II*
Syphilis*
WNV
T. cruzi (Chagas disease)
What immunohematlogic tests are done one donor blood?
-ABO (forward and reverse)
-D
-Weak D on all negative donors
-antibody screen
If significant antibodies are present in donor blood, what cannot be used?
plasma and platelets
-RBCs can be used, but the antibody interpretation should be on the
label
Required serologic testing is performed on all
donor units, that include…
-Hepatitis B surface antigen (HBsAg)
* Antibody to Hepatitis B core antigen (antiHBc)
* Antibody to Hepatitis C virus (anti-HCV)
* Antibodies to HIV (anti-HIV 1/2)
* Antibodies to HTLV (anti-HTLV-I/II
* Syphilis
* HCV RNA
* WNV RNA
* HIV-1 RNA
Confirmatory tests are used to detect false-positives. Tests vary be the disease but could include….
- Polymerase Chain Reaction (PCR)
- Western Blot (WB)
- Radioimmunoprecipitin Assay (RIPA)
- Recombinant Immunoblot Assay (RIBA)
Syphilis is caused by…
Treponema pallidum
Syphilis testing:
Screening test that detects reagin in serum
Rapid plasma reagin (RPR)
Syphilis testing:
Fixed chicken RBCs sensitized with the organism
react with patient antibodies to T. pallidum
Hemagglutination for T. pallidum
What is the confirmatory testing for Syphilis?
-Tests for specific antibody if the RPR or
hemagglutination test is positive
* Fluorescent treponemal antibody adsorption
-This testing technique can detect very low numbers of
viral copies in plasma before antibodies appear
-amplifies nucleic acids of
infectious agents and identifies viral RNA
Nucleic Acid Testing (NAT)
RNA and DNA viruses routinely tested
using NAT:
-HIV
* HCV
* West Nile virus (WNV)
* HBV
What are the advantages of chemiluminescence?
Stable
Less reagent is needed
Relatively nontoxic
Quick reagents
Very sensitive
Fast turnaround time
Ability of assay to identify
samples from infected
individuals as positive
Sensitivity
Ability of assay to identify
samples from noninfected
individuals as negative
Specificity
Hepatitis ___ and Hepatitis ___ are tested for on donors.
B, C
Hepatitis testing:
indicates that the individual is infectious***
Hepatitis B surface antigen (HBsAg
Antibody appears after HBsAG but before symptoms***
Antibody to hepatitis B core antibody (anti-HBc)
_______ antibody is detectable 10 weeks after infection*
Anti-HCV
NAT to detect _____of HCV
NAT to detect ____ of HBV*
RNA
DNA
A retrovirus contains ________________, which
allows the virus to convert RNA to DNA and then
integrate the DNA into the cell.
reverse transcriptase
What are two Human Retroviruses subfamilies?
− Lentivirus (HIV types 1 and 2)
− Oncornavirus (human T-cell lymphotropic virus [HTLV] types I, II, and V)
Donor testing for HIV types 1 and 2 require what donor testing?
-Antibody to HIV 1 and 2 develops
22 to 25 days after infection
-HIV-1 NAT
HIV infects what type of cells?
Infects CD4+ T lymphocytes
(helper T cells)
HIV types 1 and 2 cause…
acquired immunodeficiency
syndrome (AIDS)
HTLV-I is associated with?
adult T-cell leukemia
HTLV-II is associated with…
large granular lymphocyte leukemia
True or false?
It is a requirement that all donor blood be tested for antibody to HTLV types I and II
true
-Mosquito-borne flavivirus
-Clinical manifestations range from mild
fever to encephalitis, coma, and death
-Individual donors are screened for West
Nile virus using NAT
West Nile Virus
True or false?
Leukoreduction does not get rid of CMV
false, it does (the reason it dose not need to be tested for)
What products must be tested for bacterial contamination?
Apheresis platelets and platelet concentrates
Additional tests:
-Mononucleosis-like virus that is found in
white blood cells
* negative blood is given to infants or
anyone who is immunocompromised
Cytomegalovirus
Additional tests:
- Caused by Trypanosoma cruzi; transmitted by
reduviid bug - Blood collection facilities in areas with many
Latino immigrants perform an EIA test - In 2010, the FDA recommended one-time
donor screening
Chagas disease
__________ have been the most frequent source of septic transfusion reactions.
platelets
What organisms may be transfusion -transmitted but are not routinely tested for?
Hepatitis A, E, D, G
CMV
EBV
Human B19 Parvovirus
Human Herpesvirus 6 and 8
Babesia microti
Trypanosoma cruzi
Malaria (Plasmodium species)
Creutzfeldt-Jakob Disease (CJD)
The lipid-enveloped viruses, HIV, HBV, HCV, HTLV, EBV, CMV, HHV-6, and HHV-8, are all inactivated by use of…
organic solvents and detergents
Why is the risk of enveloped virus transmission very low?
-the combination of treatments such as heat treatment, solvent/detergent treatment, and nanofiltration.
-This process is not effective with nonlipid-enveloped viruses such as HAV and
parvovirus B-19.
- A __________ investigation involves actions taken when
donor test results are positive for the hepatitis virus, HIV, HTLV, or WNV
look-back
What actions are taken during a look-back investigation?
-Quarantine prior to donations from the donor
− Notify facilities that received products
− Donor is further tested
− Destroy (or relabel) prior collections
− Notify transfusion recipients
If it is noted that a patient developed HBV, HCV,
HIV, or HTLV after receiving a single unit from
one donor, that donor is…
permanently deferred.
True or false?
Autologous donations positive for HBV, HCV, HIV, HTLV, or syphilis can be used
true, they already have the disease so there is no additional harm
Any fatalities due to a TTD must be reported to the director of the Center for Biologics Evaluation and Research within ___ working day, followed by a written report within 7 days.
1
