Week 7: Donor Selection

AABB

• international association of blood bankers

• give standards of care for patients + donors regarding transfusion medicine

the FDA considers blood to be what?

a biologic and a drug

what is the FDA responsible for?

• inspecting blood banks and collection sites

• regulating blood collection and its components

• regulating reagent manufacturing

• monitoring adverse reactions and erros

every person who volunteers to donate blood products must under go a _____________ process

screening

what is the purpose of screening donors?

• ensures they are healthy

• protects recipient from adverse effects

what does the donor screening process include?

• registration

• medical history exam

• physical exam

• serologic testing of donor blood

what does donor registration include?

• demographics

• links to existing records

• last date of donation

usually ______ forms of ID are required for 1st time donation

two

minimum age of donation

17 in most states, 16 with parental consent

there is no maximum cap on _____ for donors

age

a person can donate whole blood every __________

56 days (8 weeks)

a person can donate double RBCs every ____________

112 days (16 weeks)

medical history questionaire

• gathers info about donor’s medical background

  • past illnesses

  • exposure to bloodborne pathogens

  • STDs

  • pregnancy history

  • vaccinations

  • medications

• private

• same day as donation

pregnant donors are deferred until _________ after completion of pregnancy

6 weeks

in most cases it is the ___________, not the medication that causes a deferral

disease

donors taking aspirin have a _______ deferral for donating apheresis platelets

2 days

donors taking coumadin, warfarin, or heparin have a _________ deferral

7 day

plavix (clopidogrel) and ticlid (ticlopidine) have a __________ deferral if donating platelets by apheresis

14 day

hepatitis B immune globulin for hepatitis exposure results in a __________ deferral

3 month

HIV prevention (PrEP or PEP) by mouth (Truvada or Descovy) results in a __________ deferral

3 month

injectable HIV prevention (long-acting antiviral PrEP or PEP) results in a ___________ deferral

2 year

the FDA recommends deferral for replicating live __________ virus vaccine

smallpox

without replicating live smallpox virus vaccine completion, deferral should be after the vaccination _______ has separated spontaneously or _________, whichever is later

scab, 21 days

there is an ___________ deferral if the smallpox virus vaccine scab has been removed prior to spontaneous separation

8 week

with smallpox virus vaccine complications, there is a _________ deferral after complications have completely resolved

14 day

deferral policies for other vaccines (non-smallpox) are determined by who?

collecting facility’s physician

what do the following responses on a medical history questionnaire result in?

• Sexual contact with positive HIV individual

• Sexual contact or living with positive hepatitis B or symptomatic hepatitis C
  individual

• Anal sex with a new partner

• Anal sex with more than one partner

• Received money, drugs or payment for sex

• Blood transfusion

• Organ, tissue, bone marrow transplant

• Bone or skin graft

• Tattoo, piercing, needle stick, IV drug use (not prescribed by doctor)

• Gonorrhea or syphilis following completed treatment

3 month deferral due to increased risk of transmitting infectious disease

individuals that are HIV positive are ________________ deferred from blood donation

permanently

_____________deferral if taken any medication to treat HIV infection

permanent

what if an individual has spent 72 hours or more consecutively in juvenile detention, jail, or prison?

12 month deferral due to increased risk for HIV and other transfusion transmitted infections

residents in a malaria-endemic country have how long of a deferral?

3-year

non-residents who travel to a malaria-endemic country have how long of a deferral?

3 months

if an individual had a previous infection with malaria, they are deferred until asymptomatic for ________ while residing in a non-endemic country

>3 years

a Babesia-positive individual is deferred ______________ or at least 2 years from the most recent positive test

indefinitely

individuals who received human cadaveric dura mater transplant or graft are at risk for carrying what?

Creutzfeldt-Jakob disease, and are permanently deferred

xenotransplantation patients are ______________ deferred

indefinitely

there are no US federal regulations or standards to evaluate donors with a history of ________

cancer

individuals with hemophilia or related clotting disorders are deferred ____________

indefinitely

individuals with heart or lung problems are accepted donors based on what?

case-by-case basis by collecting facility’s medical director

a donor must _______ that they read, understood, and answered all questions in the medial history questionnaire

sign

the physical examination includes:

• general appearance

• hemoglobin

• pulse

• blood pressure

• weight

• temperature

what does the general appearance assess the presence of?

• nervousness

• intoxication

• drug use

• illness

HGB and HCT requirements for male donors

• HGB >/= 13 g/dL

• HCT >/= 39%

HGB and HCT requirements for female donors

• HGB >/= 12.5 g/dL

• HCT >/= 38%

the FDA does say in the code of federal regulations that collection sites may collect blood from female allogeneic donors with a hemoglobin of 12.0 to 12.5 g/dL or a hematocrit of 36 to 38 percent, but under what conditions?

Facility must ensure that the health of the donor will not be adversely affected due to this alternative standard, by establishing a procedure that has been found acceptable for this purpose by FDA

how is the pulse conducted in the physical examination?

• 50-100 bpm

• at least 15 seconds

• irregularities → BB physician

systolic BP for donors must be what?

90-180 mmHg

diastolic BP for donors must be what?

50-100 mmHg

you must weigh at least _______ pounds to donate

110

temperature for donors must be below what?

99.5 F or 37.5 C

what is autologous blood donation?

a person donates their own blood beforehand so it can be saved and given back to them during or after a planned medical procedure or surgery

autologous blood donation must be labeled with what?

patient information and hospital it will be transfused

autologous blood donation can be donated how often?

every 4-7 days depending on physician approval

the last donation for autologous blood has to be earlier than _______ before surgery

72 hours

what are the hemoglobin and hematocrit requirement for autologous blood donation?

>/= 11 g/dL and >/= 33%

what is directed blood donation?

unit is reserved for a specific patient, with the same collection requirements as allogenic donation

directed blood units must be ____________ as such

labeled

the venipuncture site is cleaned for at least _____________ using FDA approved cleanser

30 seconds

_____________ solution is present in the sterile bags used for collection

anticoagulant

what anticoagulants are used in collection bags?

• ACD — acid citrate dextrose

• CPD — citrate phosphate dextrose

• CPDA-1 — citrate phosphate dextrose adenine

how much blood does a typical donor unit contain?

405-550 mL

a _______ tube is collected after a unit is collected

pilot

whole blood units remain at _________ if used for platelet collection

20-24 C

all other whole blood units (not platelet collection) are stored at __________

1-6 C

a low volume unit of _________ is collected in a 450 mL bag (with OG anticoagulant volume)

300-405 mL

a low volume unit of _________ is collected in a 500 mL bag (with OG anticoagulant volume)

333-449 mL

low volume units cannot be used for what?

to produce platelet or plasma components

low volume units must be __________ as such

labeled

post-donation for donors

• receiving instructions

• regaining fluids in 24 hours

• hemoglobin replenished after 2 months

mild reactions to donation

• fainting

• vomiting

• hyperventilation

moderate reaction to donation

loss of consciousness

severe reaction to donations

covulsions

what is apheresis?

• Selective removal of specific blood components

• Returns the non-targeted component back to the donor

how are specific blood components taken from donation units?

centrifugation

plateletpheresis

• Can collect single, double, or triple units from one donor

• 2 days between donations

• cannot exceed 2X a week and 24X a year

• count >150,000

plasmapheresis

• 2 days between donations, not to exceed 2X a week

• Total protein and serum protein electrophoresis or quantitative immunoglobulins must be within normal limits

to donate whole blood after apheresis plasma or platelets, one must wait at least _________

48 hours

RBC pheresis

• One unit of packed red blood cells is removed from donor

• Can donate every 8 weeks

double RBC pheresis

• Two units of RBC are removed from donor

• can donate every 16 weeks

what are the 3 main tests done to donor blood in BB?

1. ABO type

2. Rh type

3. antibody screen

a unit cannot be used for platelet or plasma if the _____________ is positive

antibody screen

if the antibody screen is positive, the whole blood unit is converted to what?

packed RBCs, while plasma is discarded

what is donor blood tested for to reduce spreading diseases?

• HIV-1 antigen

• anti-HIV-1 and anti-HIV-2

• syphilis serologic tests

• HBsAg

• anti-HBc

• anti-HCV

• anti-HTLV I/II

• T. cruzi — Chagas Disease

• west nile virus

If a screening test comes out positive for any of the markers for
infectious diseases, ____________ test is performed

confirmation

Screening test positive; Confirmatory test negative:

Blood is not used as a precaution; donor not contacted

Screening test positive; Confirmatory test positive:

Blood is not used; donor is contacted

Screening test positive; Confirmatory test indeterminate:

Blood not used; donor is temporarily deferred and re-tested later

when does a look back procedure occur?

when a donor is newly reactive for infectious disease

in a look back procedure, previously collected blood products from that donor are found, then what?

• any units currently in inventory must be quarantined or discarded

• previous recipients of these units must be notified

every unit must have a label that includes:

• donation #

• name of component

• anticoagulant

• volume

• collection facility

• expiration date

• volunteer, directed, autologous unit

• ABO type

• Rh type

what is the donor # linked to?

• donor record

• blood containers

• testing samples

• all components derived from original collection

the donor # is a 14 character number that represents:

• country of origin

• center of origin

• year of collection

• sequential number

• check digit

what does the product code include?

divisions and modifications (thawed, irradiated, washed)