The Osler Institute

Blood Bank II
D. Joe Chaffin, MD
Cedars-Sinai Medical Center, Los Angeles, CA

Blood Donation & Pretransfusion Testing

I. Blood Donation
A. Allogeneic (homologous) whole blood donation
1. Process tightly regulated by FDA and AABB
2. Donor screening by history
a. FDA-recognized AABB template called “donor
history questionnaire” (DHQ); see end of this handout
b. Necessary information
1) Full name (generally, formal ID required)
2) Home and/or work address
3) Date of birth/age to make sure over minimum age
a) 17 unless age 16 donors approved by state
4) Reasons for previous deferral
5) Date of last donation
a) > 8 weeks for whole blood
b) > 16 weeks for double red cell collections
c) > 4 weeks for infrequent plasmapheresis
d) > 2 days for single platelet apheresis procedures
e) > 7 days for double/triple platelet apheresis
c. HIV information presented to donor
1) Signs/symptoms and risk factors for HIV
2) Statement: Do not to donate if have any risk factors
or if just wanting HIV test
d. Medication list; prevents donations from those taking:
1) Medications with teratogenic potential
2) Medications with infectious risk
3) Medications that damage platelets
4) See list on page 5
e. Informed consent must spell out risks
1) Not standardized; individual centers must develop
2) Notification that other agencies might be notified of
results (e.g., state and/or local health departments)
3) Statement that blood might not be tested (lab
accidents/errors, breakage, etc.)
f. Donor questions
1) Version 1.3 of DHQ (recognized by FDA in May
2010) contains 48 standardized questions
2) May modify times only to make more restrictive
3) Most omit 2 HIV group O questions (see later)
4) May add additional questions at end only
a) These can be more restrictive only; never less
b) Commonly added questions are about
medications/health issues not covered in DHQ

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g. Deferrals based on history

1) Permanent/indefinite deferrals
Infectious Risks
-High-risk behavior for AIDS
(IVDA, male-male sexual contact since 1977)
-Receiving money or drugs for sex
-Serologic positive for HIV, HBV, HCV, HTLV
-Viral hepatitis (any) after 11th birthday
-Transfusion of clotting factor concentrates (in hemophilia)
-History of Babesiosis or Chagas’ disease
-Growth hormone from human sources (pre-1985)
-Insulin from bovine sources
-Dura mater graft
Malignancies (see below)
-Leukemia or lymphoma
Teratogens
-Taking etretinate (Tegison)
2) Three year deferrals
Infectious Risks
-Recovered from malaria
-Immigrants from malaria-endemic countries
(after 5 consecutive years of living there)
Teratogens
-Taking acitretin (Soriatane)
3) One year deferrals
Infectious Risks
-Needle sticks or other contact with blood
-Sex contact with person with HIV or hepatitis
-Sex contact with person who used needles for drugs
-Rape victims
-Incarcerated > 72 consecutive hours
-Paying money/drugs for sex
-Blood transfusion (allogeneic); including plasma/clotting
factors in nonhemophiliacs
-Allogeneic transplant of organ/skin/bone
-Living with person with active hepatitis
(exception: Asymptomatic Hepatitis C)
-Receiving Hepatitis B Immune Globulin (HBIG)
-Tattoos/piercings (unless by regulated entity)
-Travel to malaria-endemic areas for residents of non-endemic
countries (>24 hrs, < 5 years)
-Diagnosed with syphilis or gonorrhea
-Non-prophylactic rabies vaccination
-“Travel” to Iraq

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4) Special situations
a) Malaria (updated to 08/13 FDA Guidance)
• “Endemic area” means area that CDC
recommends chemoprophylaxis to travelers
• “Endemic country” means any country with at
least one endemic area
• Deferrals:
Situation Deferral
History of malaria 3 years (if asymptomatic)
Living in endemic country for more than 5 3 years (if asymptomatic)
consecutive years
Travel by residents of non-endemic countries
Travel to endemic area for more than 24 1 year (if asymptomatic)
hours and less than 5 years
Travel in endemic country but not endemic No deferral
area for more than 24 hours
Travel by previous residents of endemic countries
Travel to endemic area (prior resident of 3 years (if asymptomatic)
endemic country <3 years after leaving)
Travel to endemic area (prior resident of 1 year (if asymptomatic)
endemic country >3 years after leaving)
b) Malignancy deferrals
• Medical director discretion (not mandated)
• Studies do not show that malignancy can be
transmitted via transfusion
• Most defer leukemia/lymphoma permanently,
but some accept cured childhood leukemics
• For solid tumors, most defer indefinitely and
consider re-entry after 1-5 years disease-free
• BCC, localized skin SCC = no deferral.
c) Heart and lung disease
• No specific mandated deferrals
• FDA: Donor free of acute lung disease
• AABB: Donor should be free of heart/lung
disease unless determined suitable by medical
director
• Medical directors determine acceptability
(time since diagnosis, presence of limitations
on activities, proper medical follow-up)
d) Pregnant women: Defer until 6 wks postpartum.
e) Non-routine dental work: Defer for 72 hours.
f) Questions 46, 47: Africa questions
• These questions are omitted since all centers
use anti-HIV test sensitive for HIV group O
• No reported US cases since 1996
• Questions ask about being born, living in,
traveling to, transfused in, or sexual contact
with someone born or living in countries in
Africa since 1977

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5) Defer permanently for vCJD risk all donors who:
a) Lived over 3 months in UK, 1980-1996
b) Lived Continental Europe > 5 years, 1980-now
c) Were transfused in the UK, 1980-now
d) Received dura mater transplant, pituitary growth
hormone injections, or bovine insulin injection
e) Have family history of CJD or vCJD
f) Were military members/dependents:
• Stationed at Northern Europe bases
(Germany, UK, Belgium, Netherlands) for 6
months from 1980-1990
• Stationed at other Europe bases (Greece,
Turkey, Spain, Portugal, Italy) for 6 months
from 1980-1996
6) Immunizations
a) General rule: no deferral for killed, toxoid, or
recombinant/synthetic vaccines
b) Live attenuated vaccines (either viral or
bacterial) give deferrals of varying lengths

Immunization Deferrals
Four Weeks: Rubella
Varicella
Two Weeks: Measles
Mumps
Oral polio
Yellow fever
Oral typhoid
No Deferral: Anthrax
Cholera
DPT
Hepatitis A
Hepatitis B
Influenza
Lyme disease
Meningococcus
Pneumococcus
Polio (injection)
RMSF
Typhoid (injection)
12 Months: Unlicensed vaccines

c) Smallpox vaccination
i) Deferrals based on presence/ absence of
vaccine scab and post-vaccination symptoms
ii) No symptoms: defer until scab falls off or 21
days, whichever is longer
iii) With symptoms: defer until 14 days after
symptoms resolve

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7) Drugs
a) DHQ only requires questioning about a limited
number of medications
i) Some facilities add more to protect donor
b) DHQ V 1.3 drug deferrals for teratogenicity:
i) Etretinate (Tegison): Permanent deferral
ii) Acitretin (Soriatane): Three year deferral
iii) Isotretinoin (Accutaine, Absorica,
Amnesteem, Claravis, Sotret): 30 day
deferral
iv) Finasteride (Proscar, Propecia): 30 days
v) Dutasteride (Avodart, Jalyn): 6 months
c) DHQ V 1.3 drug deferrals for infection risk:
i) Human pituitary growth hormone: Permanent
ii) Bovine insulin: Permanent
iii) Hep B Immune Globulin (HBIG): 1 year
iv) Unlicensed vaccine: 1 year
d) Aspirin/aspirin like meds for platelets (48 hours)
e) Platelet drug deferrals:
i) Piroxicam (Feldene): 48 hours for platelet
donors only
ii) Clopidogrel (Plavix) and ticlopidine (Ticlid):
2 weeks for platelet donors only
f) Warfarin is not addressed in DHQ, but most
defer donors 7 days
g) New drugs are fast arriving
i) Antiplatelet and anticoagulant drugs seen in
donors (e.g., Brilinta, Pradaxa, Xarelto)
ii) Medical director discretion, but most are
deferring like warfarin
3. Donor screening by physical criteria
a. General appearance
b. Arm check
1) Both arms for evidence of IVDA and venous access
c. Physical requirements (weight, BP, pulse are not
standards but most common practice):

Weight: > 110 lbs (50 Kg)

Temperature: < 99.5o F (37.5 C)
Pulse: 50-100 (unless athlete)
Blood pressure: < 180/100
HGB or HCT: > 12.5 g/dL or 38%
4. Donation specifics
a. Amount drawn
1) Maximum of 10.5 ml/Kg is allowed by AABB
2) 500 +/- 50 mL (+/– 10%) most common
a) 450 mL bag also used; limit is 450 +/- 45 mL

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b. Time limit
1) < 10 minutes best, but no upper limit defined
a) Beyond 15 minutes, plasma/PLTs not made
5. Testing donor blood (Collection center)
a. ABO grouping
b. RhD typing
1) Weak D required if D negative (see BBI)
c. Antibody detection (“screen”)
1) Unexpected (non-ABO) antibodies in donor serum
2) AABB Standards: If positive, may still use blood,
but only to make products with minimal plasma
(i.e., RBCs ok; can’t make FFP, cryo, or platelets).
3) Label must reflect any positive results that are
identified as clinically significant antibodies.
4) Reality: Most hospitals don’t want this blood
d. Infectious disease screening (as of 2/2014); see
appendix and further details starting on page 13
1) Hepatitis B Tests
a) HbsAg
b) Anti-HBc
c) HBV nucleic acid test (HBV NAT)
2) Hepatitis C Tests:
a) Anti-HCV
4) HCV NAT
3) HIV tests:
a) Anti-HIV-1/2
b) HIV-1 NAT
4) Other tests:
a) Anti-HTLV-I/II
b) West Nile virus NAT
c) Anti-Trypanosoma cruzi (Chagas’ disease)
d) Serologic test for syphilis
6. Testing donor blood (Transfusion Service)
a. Requires confirmation of collection center’s work
b. Confirmatory tests:
1) ABO grouping (RBC grouping only)
2) RhD-negative confirmation
a) Direct testing only of units labeled as D–
b) Weak D testing not required (done already)
c) Units labeled as D+ do not require confirmation
3) Antibody screen and infectious disease screening on
donor units do not require confirmation
B. Donor reactions
1. Vasovagal reactions
a. Most common reaction (2.5% of healthy donors)
1) Most common in young, first-time female donors
2) Can be seen in any donor, though
3) Can happen before, during, or after donation

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b. Signs/symptoms
1) Bradycardia (or at least, non-tachycardia) with
hypotension
2) Syncope
3) Nausea/vomiting
4) Incontinence (uncommon)
c. Treatment is supportive
1) Distinguish from hypotensive shock
2) Elevate feet, cold compresses on neck
2. Hypovolemic shock
a. Extremely uncommon
b. Signs/symptoms
1) Tachycardia with hypotension
2) Loss of consciousness
3) Shock parameters
c. Treatment
1) IV fluids, possibly return blood?
3. Hyperventilation
a. Especially common in first-time donors and children
b. Signs/symptoms
1) Shortness of breath
2) Facial twitching
3) Seizure activity (unusual)
c. Treat with rebreathing (the paper bag thing)
4. Local injuries
a. Hematomas: 0.35% (bruises almost 25%)
b. Nerve injury: less common than bruises (0.9%);
usually resolve on their own
C. Apheresis procedures
1. Separation of blood into components using several
technologies
a. Centrifugation used for donor procedures (others for
therapeutic procedures; see BB Practical section)
b. Separation based on varying density of blood
components
c. Blood drawn into spinning bowl or chamber,
separated, component harvested (all else returned).
2. Targets for donor collection
a. Platelets
b. Plasma
c. Red blood cells
d. Granulocytes
e. Hematopoietic stem cells (after mobilization)
3. Multiple product collections in one procedure possible
a. Common to get single/double/triple apheresis unit with
concurrent plasma collection
b. May also add an RBC collection
c. “Double” RBC collections (no other products)

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4. Donor requirements
a. Platelet donors
1) Same hemoglobin/hematocrit requirements as
regular donors
2) Donation interval at least 2 days for single product
(7 days for double/triple/quad)
a) No more than 2 procedures per week
b) No more than 24 procedures per year
c) > 8 weeks after whole blood donation or if
RBCs not returned (unless equipment has less
than 100 mL extracorporeal volume)
d) Physician may waive above if for a particular
patient need (requires written certification).
3) Donation interval 7 days after double/triple products
4) No aspirin/aspirin-effect products in last 48 hrs
5) No clopidogrel or ticlopidine in last 14 days
6) Pre-procedure platelet count > 150,000/L (may use
previous count if not available)
7) Plasma volume loss as per manufacturer
b. Plasma donors
1) “Infrequent” (> every 4 weeks): = whole blood
2) “Serial” (< every 4 weeks):
a) Total protein and SPEP check every 4 months
b) Interval > 48 hours; < 2 collections per 7 days
c) Red cell loss < 25 mL/week, < 200 mL/8 weeks
c. Double red cell donors
1) FDA: “Assure donor safety”
2) Equipment makers have donor requirements that are
OK’ed by FDA when machine is FDA-cleared
3) Double red cell donors are deferred for 16 weeks
d. Multiple products collected at once
1) FDA-cleared equipment specific donor limits
5. Apheresis donor reactions
a. “Citrate effect”
1) Citrate anticoagulant binds free calcium
2) Perioral tingling
3) Tetany and arrhythmias uncommon
4) Slow rate of infusion, give oral calcium
b. Hypersensitivity reactions
1) Classic: Hydroxyethyl starch in WBC donors
a) Given to facilitate better separation of WBCs
from RBCs by inducing RBC aggregation
b) Occasional hypersensitivity reactions seen
II. Autologous Blood Collection
A. Preoperative autologous blood donation (PAD)
1. Less screening stringency than allogeneic collections
2. AABB Standards: Don’t “cross over” units into regular
inventory unless exceptional circumstances

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3. More lenient physical criteria (see table below)
4. Testing regulations
a. Infectious disease screening not required unless units
are to be shipped to another facility
1) Hospital centers collecting auto units for transfusion
are not required to screen those units
2) If not tested, label units “NOT TESTED”
b. Only first donation in a 30-day period MUST be tested
1) Others after that may be labeled “DONOR
TESTED WITHIN THE LAST 30 DAYS”
Parameter Allogeneic Autologous
Donation Interval 8 weeks 72 hours
HB/HCT > 12.5 or 38% > 11 or 33%
Weight > 110 lbs (50 Kg) None
Age > 16 or 17 (varies) None
Infectious Disease Not required unless
Required
Screening shipped
History of Disease
Not eligible Potentially eligible
or Positive Test
5. Potential issues with autologous donations
a. Donor reactions
1) More complex donors with more health problems,
so more likelihood of donor complications
2) Safety of donor during donation is responsibility of
donor center medical director!
b. Clerical errors/transfusion errors
1) Risk of wrong unit going to wrong patient still
present with autologous donations
2) CAP survey (1992): about 1% of hospitals admitted
making transfusion errors with autologous blood
3) Systems must be in place to prevent allogeneic units
from being transfused before autologous units
c. Bacterial contamination
1) Currently a greater risk than HIV or HCV
2) Risk of undetected infection leading to
contamination of unit is not changed by PAD
d. Cost
1) More costly to patients if transfused and hospitals if
not transfused (wastage)
e. Timing
1) Collections should be completed at least 72 hours
before surgery (preferably sooner)
2) Surgery cancellations, etc, can lead to problems
(freeze units? Let them expire?)
f. Positive infectious disease testing
1) If donor has a reactive test, donor and the requesting
physician must be notified

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2) Autologous collections with reactive testing should
lead to deferral from future allogeneic donations
B. Acute Normovolemic Hemodilution (ANH)
1. Primary goal: Reduce RBC volume during surgery in
order to prevent exposure to allogeneic blood
a. Studies to date: May work ok, but only with aggressive
hemodilution
b. Can save exposure, but isn’t very cost effective
2. Added benefit: Reduce plasma and platelet needs
3. Remove 1 L or more of blood immediately before surgery
a. Collection is done into multiple standard blood bags
and each bag should be monitored for overfill
b. Standard formulae exist for collection amount;
typically take patients down to HCT 25-28% or so
1) V = EBV x (Hi-Hf)/Hav (source: Waters JH,
“Perioperative Blood Sequestration”, AABB 2008)
2) Key:
i) V = volume to remove
ii) EBV = estimated blood volume
iii) Hi = initial hematocrit
iv) Hf = final hematocrit
v) Hav = average hematocrit during process
c. Shelf life:
1) 8 hours at room temperature
2) 24 hours in monitored refrigerator
4. Replace volume with saline/crystalloid (3 ml per 1 ml of
blood removed) or colloid (1 ml per ml of blood removed)
a. Replace the volume unit by unit; i.e., when a unit is
withdrawn, immediately replace volume (don’t remove
a bunch of blood and THEN correct the volume)
5. Re-infuse blood near end of surgery.
a. Units usually re-infused in reverse order to how drawn
(i.e., last drawn is first re-infused)
b. If using intraoperative salvage, infuse those units first
6. Indications (not standardized)
a. At least 1 L blood loss anticipated in surgery
b. Hemoglobin at least 12 g/dL
c. No active cardiac or other serious medical disease
d. No infection or bacteremia
7. Potential advantages
a. Bleeding more dilute blood leads to less overall
hemoglobin loss (not as huge a benefit as predicted).
b. Decreased blood viscosity increases cardiac output and
may improve oxygenation.
c. Coag factors and platelets survive well for short
periods and help hemostasis.
8. Potential disadvantages
a. Requires training of phlebotomist (most commonly
done by anesthesiologist)

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b. Units should be labeled with full name, date/time,
medical record number, and “FOR AUTOLOGOUS
USE ONLY.”
9. Component sequestration:
a. Similar in thought to ANH, but involves harvesting
specific components (platelets, plasma, RBCs) for
targeted transfusion depending on patient needs
b. More complex and requires lots of expertise
C. Intraoperative blood salvage (“Cell Saver”)
1. Semi-automated process; usually involves processing and
concentrating shed blood from suction apparatus
2. Generally indicated for major surgeries with large
expected blood losses (cardiac, orthopedics, vascular)
a. Requires coordination with team performing recovery
b. Trend: More aggressive use in lower-risk cases
3. Shelf life:
a. 4 hours at room temperature
b. 24 hours in monitored refrigerator
4. Potential problems
a. Air or amniotic fluid embolus risk
b. Hemolysis of processed blood from excessive suction
in the operative field
c. Coagulation factor activation
5. Historical contraindications; Not uniformly used
a. Bacterial contamination of operative field
b. Malignant cells in field
c. Other contaminants in field (cement, irrigation,
amniotic fluid, etc)
D. Postoperative blood salvage
1. Blood reinfused from operative drains with or without
processing (Editorial comment: That is just gross!)
a. Microaggregate filters used during re-infusion
2. Shelf life: 6 hours at room temperature
III. Pretransfusion Testing

A. Basic outline (see figure above)

1. Requires actions by supplier, phlebotomists, transfusion
services, and infusing staff
2. Crossmatch is final check of everyone’s work
a. Main reason for crossmatch: ABO compatibility!
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B. Testing recipient blood
1. Request forms
a. Identification critical
1) Number one cause of fatal HTR’s: clerical error!
b. No identification labeling errors are acceptable.
1) Transfusion 1997 37; 1169-72: Mislabeled
specimens 40X more likely to have a blood
grouping discrepancy!
c. Should tell what’s needed and when needed, ordering
provider, and any modifications (washing, irradiation,
etc.) needed
2. Specimen
a. Serum or plasma (red top vs lavender top)
1) Either ok, but non-tube technologies prefer plasma.
b. Required q 3 days with transfusion or pregnancy in
the last three months
c. Retained 7 days after transfusion in the blood bank.
3. Type and hold (T&H)
a. ABO/Rh check only
b. “Hold” means to hold sample, not units.
c. Uncommonly used or even offered now
4. Type and screen (T&S)
a. Includes:
1) Records check
a) Previous antibodies or compatibility problems
b) Not to be used to determine current ABO/Rh,
but should be compared to current results.
2) ABO testing
a) Forward and reverse grouping
b) Resolve any discrepancies
3) Rh typing
a) No weak D test required if D negative.
• Common exception: obstetric patients
4) Antibody screen
a) “Unexpected” (non-ABO) antibody check
b) Panel of 2, 3, or 4 RBC-phenotyped donors
i) Always group O
ii) Most common combination:
• Cell I: R1R1
• Cell II: R2R2
• Cell III: rr (cell III not used with gel)
c) Antigens represented required by FDA:
i) D, C, c, E, e, Fya, Fyb, Jka, Jkb, K, k, Lea, Leb,
M, N, P1, S, s
d) IAT phase is required, IS/37 C are not required.
e) If positive, identify antibody (see BB Practical)
5. Type and crossmatch (T&C)
a. Everything in T&S + crossmatch

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b. Crossmatch types
1) Major crossmatch (or just “crossmatch”)
a) Recipient serum vs donor RBCs
b) Final check of ABO compatibility
c) IAT/AHG phase (“full crossmatch”) not required
if antibody screen is negative
d) Required if ≥ 2 ml of RBCs in product.
2) Minor crossmatch (not required or routinely done)
a) Donor serum vs. recipient RBCs
3) Units go back into inventory if not used
6. Converting a T&S to a T&C
a. ABO check only required (if antibody screen negative)
1) Immediate spin crossmatch
a) Donor RBCs/recipient serum centrifuged at
room temp
2) Computer crossmatch (see below)
7. Variations to the above
a. Infants less than four months of age (neonatal period)
1) Baby’s antibodies = mom’s IgG antibodies.
2) Initial testing:
a) Infant’s ABO (red cell grouping only)
b) Infant Rh type
c) Antibody screen on mom’s or baby’s serum.
3) If screen neg, repeat initial testing and crossmatch
not needed in same hospital stay up until age 4
months
4) Serum grouping not required unless giving non-
group O RBCs
b. Electronic (computer) crossmatch
1) Computer system verifies ABO compatibility
between donor and recipient (replaces immediate
spin crossmatch)
2) Requires a patient with a negative antibody screen
both now and in the past
3) Requires two separate ABO determinations of the
patient (either on different specimens or repeated on
the same specimen with different reagents)
4) Requires a properly validated computer system
8. Reasons for positive major crossmatch
a. With positive antibody screen
1) Alloantibodies
2) Autoantibodies
3) Reagent antibodies
4) Rouleaux and other false positives
b. With negative antibody screen
1) ABO incompatibility
2) Antibodies vs low-incidence antigens
3) Positive donor DAT

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9. Routine blood order templates
a. Maximum Surgical Blood Ordering Schedule
(MSBOS), or just “routine surgical blood orders”
b. Multidisciplinary and institution-specific
c. Gives surgeons / blood bankers a guide to how many
RBC units to crossmatch (or not) for a given procedure
IV. Transfusion-transmitted Diseases (See April
2011 Podcast)
A. Current risk of disease transmission
1. For perspective, risk of acute hemolytic reaction stated as
1 in 25,000 transfusions
2. Risk of dying in the hospital from something other than
transfusion problem: 6 per 1000!
Organism Current Risk Estimate
HIV-1 1 in 1,467,000
Hepatitis B 1 in 765,000-1,000,000
Hepatitis C 1 in 1,149,000
HTLV-I 1 in 4,364,000
HIV-2 Remote
WNV Remote
Syphilis Remote
T. cruzi Unknown, likely remote
Bacteria 1 in 75,000 platelet transfusions
1 in 500,000 RBC transfusions
B. Hepatitis viruses
1. Hepatitis A virus
a. Fecal-oral transmission (30 day incubation)
b. Generally not a big blood banking problem (not tested)
c. Some concern in pooled products
1) Solvent-detergent treatment doesn’t deactivate
HAV (nonenveloped).
2) Transmission possible in pooled factor concentrates
d. Not prone to chronicity like HBV and especially HCV
2. Hepatitis B virus
a. DNA virus (Hepadnavirus)
b. Blood transmission, intimate contact less likely
c. Both cellular and plasma components transmit.
d. Incubation period: approximately 8-12 weeks
e. Clinical
1) Primary infection may be subclinical (65%) or only
mild (jaundice, nausea, fatigue, dark urine).
2) Fulminant presentation rare
3) Chronic infection (“carrier state”) much less likely
than with HCV (< 5% of adult infections)
a) Greatly decreased carriers since routine
vaccination
b) 400 million worldwide carriers, per WHO

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f. Current testing (see appendix)
1) Anti-HBc EIA/ChLIA and HBsAg EIA/ChLIA
a) Confirmatory test for HBsAg: neutralization
b) No confirmatory test for anti-HBc
2) HBV NAT now required (done in combination with
HIV and HCV)
3) No anti-HBsAg testing (vaccinated donors positive)
4) HBV is currently the most likely of the major
viruses to be transmitted via transfusion!
g. Serology patterns below
HBV ANTI-HBc ANTI-HBc ANTI-
HBsAg INTERPRETATION
DNA (TOTAL) (IGM) HBsAg
– – – – – Incubation
+ + + + – Acute infection
– – + – + Recovered infection
+/– + + – – Carrier
– – – – + Vaccinated
Probable false pos.,possible
– – + – – early or chronic infection
h. Deferrals with HBV NAT (source: FDA Guidance
2012):

3. Hepatitis C virus
a. RNA virus
b. 0.5-1.0% of US blood donors
c. Both cellular and plasma components transmit.
d. Strong association with chronic hepatitis (75%),
cirrhosis, and hepatocellular carcinoma (>HBV)
1) Currently #1 reason for hepatic transplant in the US.
2) Initial presentation mild or asymptomatic
e. Donor testing (see appendix)
1) Antibody test is anti-HCV (EIA/ChLIA)
a) Window period with antibody test: 70-80 days

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b) During some of this time, HCV RNA is
detectable by PCR testing, and the virus is
transmissible by transfusion (see below).
c) Confirmation:
i) Reactive anti-HCV historically confirmed by
Recombinant ImmunoBlot Assay (RIBA);
NOT AVAILABLE
ii) Instead, confirm either with a different EIA
(requires FDA variance) OR with a specific
HCV NAT licensed for supplemental testing
2) Nucleic acid testing (HCV NAT)
a) Window period from 70-80 days to about 7 days
b) Typically done in combination with HBV and
HIV NAT
3) See appendix for deferral guidelines
4. Other hepatitis viruses we don’t test for:
a. Hepatitis D virus
1) Formerly known as “delta agent”
2) Blood transmission
3) “Defective” virus (requires coating with HBsAg in
order to cause disease).
b. Hepatitis E virus
1) Fecal-oral transmission
2) Epidemics in India and Asia; rare transfusion
transmission
C. Retroviruses
1. HIV-1 and HIV-2
a. RNA retrovirus identified in 1984
1) Hemophiliacs and homosexual men first
2) Transfusion, sexual contact, breast-feeding, blood
b. Clinical/pathophysiology
1) Symptoms in acute infection: “flu-like”
2) LONG asymptomatic period (often over ten years),
then rapid immune compromise
3) Damage caused by attack on CD4+ lymphocytes
4) Death secondary to opportunistic infections or
malignancies like Kaposi’s or CNS lymphoma
c. Testing
1) Antibody testing
a) Required since 1985
b) Window period = 20-22 days
2) Organism testing
a) HIV-1 antigen (p24) testing March 1996
• Reduced window period to about 16 days
b) p24 testing replaced in 1999-2000 by nucleic
acid testing for HIV RNA (HIV NAT)
• Reduction of window period to 9-10 days
d. Both cellular and plasma products can transmit HIV-1
e. See appendix for deferral guidelines

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f. HIV-2
1) Related virus found originally in West Africa
2) Really, really rare
3) Less readily transmitted vs HIV-1, with less AIDS
4) No licensed confirmatory test
2. HTLV I/II
a. Transmission through cellular products only
b. HTLV-I disease associations
1) Adult T-cell leukemia/lymphoma (ATLL)
2) HTLV-associated myelopathy (HAM; formerly
called “tropical spastic paraparesis”)
c. HTLV-II: no clear-cut disease associations
d. Both transmitted readily, but actual post-transfusion
disease is very unlikely (~99% of infected no disease)
e. See testing discussion in appendix
D. Other organisms for which we test:
1. West Nile virus (WNV)
a. RNA virus causing disease in birds; humans incidental
(most flu-like, some meningitis/encephalitis)
b. 2012 large increase in cases in US
c. Testing done via pooled NAT (until high risk of
disease in area, then single donor)
d. Deferrals:
1) Confirmed/suspected WNV infection: 28 days from
symptom onset or 14 days after symptoms resolved
2) Positive test only: 120 days from test date
2. Trypanosoma cruzii (Chagas’ disease)
a. Transmitted through bite of reduviid bug (“kissing
bug”) in Central/South America
b. Potentially growing problem with immigration
(roughly 1 in 20,000 donors, higher in immigrants)
c. Specific question on donor questionnaire (permanent
deferral for history of Chagas’ disease); the problem is
that many are asymptomatic.
d. Screening test (EIA) required as of 2011
1) Testing allowed to be one time per lifetime of donor
3. Treponema pallidum
a. Organism doesn’t survive well in refrigerated storage
(48-96 hours); not considered a large problem
b. Surrogate marker for high-risk behavior
c. See testing discussion in appendix
4. Cytomegalovirus (CMV)
a. Extremely common DNA virus (> 50% are exposed)
that lives in WBCs only (monocytes).
b. Causes severe infections in immunocompromised
adults and neonates, but minimal disease in healthy
people (may have cold-like symptoms)
c. Prevent with seronegative donors and leukocyte
reduced products (see discussion in BB III)

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Pathology Review Course
d. Testing not required but available
5. Parvovirus B19
a. Primarily infects RBCs
1) Entry through P antigen receptor
b. “Fifth disease” in children, red cell aplasia in adults
c. Nonenveloped, so not destroyed by solvent-detergent
treatment (concern in pooled treated products)
d. Source and recovered plasma for plasma derivative
manufacture are tested for Parvovirus via NAT
E. Other organisms for which we don’t test:
1. Prion disease
a. Prion: probably an infectious protein particle
b. Creutzfeldt-Jakob Disease (CJD)
1) Mostly sporadic (occasionally familial) spongiform
encephalopathy, nearly universally fatal
2) Found in older patients
3) Long disease course
4) Transmission via transfusion theoretical only
c. Variant CJD (vCJD)
1) Emerging syndrome in the United Kingdom
2) Caused by prion that causes bovine spongiform
encephalopathy (“mad cow” disease)
3) Distinct from CJD (younger, more rapid course)
4) Transfusion transmission proven
5) US deferral of many donors who lived in UK or
Europe since 1980 (see earlier)
6) Led to universal leukoreduction in many countries
(but current research suggests prion may also be
found in plasma)
2. Plasmodium species
a. Malaria is readily transmissible through transfusion.
b. No effective screening except by history.
c. See earlier for deferral guidelines
3. Babesia species
a. Tick-borne intraerythrocytic parasite infection
b. Huge concern in endemic areas in East currently; pilot
studies to test donors
c. Caused 10 cases of transfusion fatality from 2007-11
d. Screen via history (permanent deferral)

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APPENDIX I
Blood Donor Infectious Disease Screening Tests
Agent Screening Test(s) Confirmatory Test(s) Discussion
HIV  Anti-HIV 1/2  EIA/ChLIA: Western blot  RR anti-HIV + Reactive HIV NAT = permanent
(EIA/ChLIA) (WB) or IFA for HIV-1 deferral
 HIV-1 NAT (PCR,  EIA/ChLIA: HIV-2 EIA  RR anti-HIV + WB neg/indeterm + NR HIV NAT =
TMA) required after reactive indefinite deferral (may try to re-enter in 8 weeks)
anti-HIV-1/2  RR anti-HIV + positive WB = permanent deferral
 NAT: Individual donor  NR anti-HIV + reactive HIV NAT = indefinite deferral
NAT (if not done) (may try to re-enter in 8 weeks)
HCV  Anti-HCV  EIA/ChLIA: Repeat EIA  RR anti-HCV + reactive HCV NAT = permanent
(EIA/ChLIA) with another EIA (under deferral
 HCV NAT FDA variance) or  RR anti-HCV + RIBA neg/indeterm (unconfirmed
(PCR/TMA) approved supplemental supplement) + NR HCV NAT = indefinite deferral
NAT versions (may try to re-enter in 6 months)
 RIBA for anti-HCV EIA  RR anti-HCV + positive RIBA (confirmed
(not currently available) supplement) = permanent deferral
 NAT: Individual donor  RR anti-HCV + RR anti-HCV (different platform) OR
NAT (if not done) positive supplemental NAT = permanent deferral
 NR anti-HCV + reactive HCV NAT = indefinite
deferral (may try to re-enter in 6 months)
HBV  HBsAg  EIA/ChLIA:  RR anti-HBc x 1 = no deferral
(EIA/ChLIA) Neutralization for HBsAg,  RR anti-HBc x 2 = permanent deferral
 Anti-HBc none for anti-HBc  RR anti-HBc + RR HBsAg = permanent deferral
(EIA/ChLIA)  NAT: Individual donor  RR HBsAg + confirmed neutralization = permanent
 NAT HBV NAT (if not done) deferral
(Required 2013)  RR HBsAg + nonconfirmed neutralization = retest in >
8 weeks
 NAT HBV reactive + RR HBsAg (confirmed
neutralization) = permanent deferral
HTLV-I/II  Anti-HTLV-I/II  None licensed  Reactive anti-HTLV-I/II x 1 = no deferral
(EIA/ChLIA)  Reactive anti-HTLV-I/II x 2 = permanent deferral
Syphilis (T.  Many (hemag-  Usually FTA or TP-PA  Reactive screen + negative confirm = no definite
pallidum) glutination, EIA, deferral (though many will defer)
RPR)  Reactive screen + reactive confirm = at least 1 year
deferral (after treatment)
West Nile  WNV NAT  Individual donor NAT (if  Reactive NAT = 120 day deferral (if asymptomatic)
Virus (PCR/TMA) not done)
Chagas  T. cruzi  Enzyme Strip Assay  Reactive EIA = permanent deferral
Disease (T. EIA/ChLIA (ESA); FDA approved  ESA and RIPA results only for counseling
cruzi)  Many use RIPA (not FDA  No re-entry currently
approved)  Testing may be once per lifetime only
RR: Repeat reactive
EIA/ChLIA: Enzyme immunoassay or chemiluminescent immunoassay
PCR/TMA: Polymerase chain reaction or transcription-mediated amplification (available US NAT
platforms)
IFA: Immunofluoresence assay
RIBA: Recombinant immunoblot assay (NOTE: RIBA has been discontinued by manufacturer, and all
protocols using it are unavailable; see strikethrough text above)
FTA: Fluorescent treponemal antibody
TP-PA: Treponema pallidum particle agglutination
RIPA: Radioimmunoprecipitation assay
RPR: Rapid plasma reagin
Sources: AABB Technical Manual, 17th ed, www.fda.gov

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APPENDIX II
AABB Uniform Donor History Questionnaire (V 1.3, AABB 2008)
Question Comment
Are you:
1. Feeling healthy and well today?
2. Currently taking an antibiotic? Medical director discretion
3. Currently taking any other medication for an Same
infection?
Please read the Medication Deferral List
4. Are you now taking or have you ever taken any See deferrals listed
medications on the Medication Deferral List? previously in notes
5. Have you read the educational materials? Includes HIV risk info
In the past 48 hours
6. Have you taken aspirin or anything that has 48 hour deferral as sole
aspirin in it? source of platelets per FDA
In the past 6 weeks
7. Female donors: Have you been pregnant or are This question (as well as #24
you pregnant now? (Males: check “I am male.”) and #34) serves as a
“check” to make sure
donors are paying attention
In the past 8 weeks have you
8. Donated blood, platelets or plasma? See details in notes
9. Had any vaccinations or other shots? See notes
10. Had contact with someone who had a smallpox No deferral unless
vaccination? symptomatic. If so, defer at
least 14 days.
In the past 16 weeks
11. Have you donated a double unit of red cells 16 week donation interval
using an apheresis machine?
In the past 12 months have you
12. Had a blood transfusion? 1-year deferral
13. Had a transplant such as organ, tissue, or bone 1-year deferral
marrow?
14. Had a graft such as bone or skin? 1-year deferral (unless dura
mater, then permanent)
15. Come into contact with someone else’s blood? 1-year deferral
16. Had an accidental needle-stick? 1-year deferral
17. Had sexual contact with anyone who has 17-23 are all 1-year
HIV/AIDS or has had a positive test for the deferrals from the time of
HIV/AIDS virus? last contact
18. Had sexual contact with a prostitute or anyone
else who takes money or drugs or other payment
for sex?
19. Had sexual contact with anyone who has ever
used needles to take drugs or steroids, or
anything not prescribed by their doctor?
20. Had sexual contact with anyone who has
hemophilia or has used clotting factor
concentrates?

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21. Female donors: Had sexual contact with a male
who has ever had sexual contact with another
male? (Males: check “I am male.”)
22. Had sexual contact with a person who has
hepatitis?
23. Lived with a person who has hepatitis? 1 year deferral, unless
asymptomatic Hepatitis C
24. Had a tattoo? For 24-25, these can be
allowed if certified that
procedure was done by
state-certified entity using
sterile, one-time use needles
25. Had ear or body piercing?
26. Had or been treated for syphilis or gonorrhea? 1 year following treatment
completion (or from time of
positive test if no symptoms)
27. Been in juvenile detention, lockup, jail, or 72 hours is consecutive
prison for more than 72 hours?
In the past three years have you
28. Been outside the United States or Canada? Primarily for malaria
exposure or vCJD risk
From 1980 through 1996,
29. Did you spend time that adds up to three (3) For 29-32, see vCJD
months or more in the United Kingdom? discussion in notes;
(Review list of countries in the UK) permanent deferral
30. Were you a member of the U.S. military, a
civilian military employee, or a dependent of a
member of the U.S. military?
From 1980 to the present, did you
31. Spend time that adds up to five (5) years or
more in Europe? (Review list of countries in
Europe.)
32. Receive a blood transfusion in the United
Kingdom or France? (Review list of countries
in the UK.)
From 1977 to the present, have you
33. Received money, drugs, or other payment for Permanent deferral
sex?
34. Male donors: had sexual contact with another Currently controversial, but
male, even once? (Females: check “I am permanent deferral
female.”)
Have you EVER
35. Had a positive test for the HIV/AIDS virus? May require investigation to
determine if true positive. If
so, permanent deferral
36. Used needles to take drugs, steroids, or anything Permanent deferral.
not prescribed by your doctor? Includes obvious physical
stigmata of IVDA (needle
tracks)
37. Used clotting factor concentrates? Permanent if for hemophilia,
otherwise 1 year deferral
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38. Had hepatitis? Permanent deferral after
11th birthday
39. Had malaria? 3 year deferral
40. Had Chagas’ disease? Permanent deferral
41. Had babesiosis? Permanent deferral
42. Received a dura mater (or brain covering) graft? Permanent deferral for
vCJD possibility
43. Had any type of cancer, including leukemia? Medical director discretion
(see discussion in notes)
44. Had any problems with your heart or lungs? Medical director discretion
(see discussion in notes)
45. Had a bleeding condition or a blood disease? If hemophilia, permanent
deferral. Otherwise, medical
director discretion.
46. Had sexual contact with anyone who was born See HIV group O discussion
in or lived in Africa? in notes. Can be omitted if
anti-HIV test used detects
group O.
47. Been in Africa? HIV group O discusssion

48. Have any of your relatives had Creutzfeldt- Permanent deferral

Jakob disease?

Medication Deferral List

(Source: http://www.aabb.org/resources/donation/questionnaires/Pages/dhqaabb.aspx)

Please tell us if you are now taking or if you have EVER taken any of these medications:
 Proscar (finasteride)  usually given for prostate gland enlargement
 Avodart, Jalyn (dutasteride)  usually given for prostate enlargement
 Propecia (finasteride)  usually given for baldness
 Accutane, Absorica (Amnesteem, Claravis, Sotret, isotretinoin)  usually given for severe
acne
 Soriatane (acitretin) – usually given for severe psoriasis
 Tegison (etretinate) – usually given for severe psoriasis
 Growth Hormone from Human Pituitary Glands  used usually for children with delayed
or impaired growth
 Insulin from Cows (Bovine, or Beef, Insulin)  used to treat diabetes
 Hepatitis B Immune Globulin – given following an exposure to hepatitis B.
NOTE: This is different from the hepatitis B vaccine which is a series of 3 injections
given over a 6 month period to prevent future infection from exposures to hepatitis B.
 Plavix (clopidogrel) and Ticlid (ticlopidine) – inhibits platelet function; used to reduce the
chance for heart attack and stroke.
 Feldene – given for mild to moderate arthritis pain
 Experimental Medication or Unlicensed (Experimental) Vaccine – usually associated
with a research protocol

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