More Related Content Similar to Taller Banco de Sangre - Seleccion donantes (20) More from faquintero (20) Taller Banco de Sangre - Seleccion donantes1. 4
Donor Selection and
Blood Collection
B l o o d c e n t e r s an d
transfusion services depend on volun-
and Transfusion Services1 for AABB ac-
creditation. The manual must reflect lo-
tary donors to provide the blood neces- cal, state, and federal regulations per-
sary to meet the needs of the patients taining to blood bank operation and
they serve. To attract volunteer donors must be reviewed at least annually by a
initially and to encourage their contin- knowledgeable person. The medical di-
ued participation, it is essential that con- rector must approve changes in proce-
ditions surrounding blood donation be
as pleasant, safe, and convenient as pos-
dures that relate to the safety of patients 4
and donors.
sible. The SOP manual should include de-
scriptions of:
1. Criteria used to determine donor
suitability.
2. Methods of performing tests to
Blood Donation Process qualify donors, including mini-
The donor area should be attractive and mum and maximum acceptable
open at hours convenient for donors, values and the policies and proce-
and must be well-lighted, comfortably dures governing qualifications of
ventilated, and clean. Personnel should nonroutine donors.
be friendly, understanding, professional, 3. Solutions and methods used to pre-
and well-trained. pare the phlebotomy site.
Each blood bank must have a manual 4. Labeling processes used to relate the
detailing its standard operating proce- original unit, postcollection tubes,
dures (SOPs). The SOP manual must in- and all components to the donor.
dicate actual practices and cover all 5. Procedures for drawing blood, in-
phases of activity in the donor area. The cluding precautions taken to ensure
procedures must meet the requirements that no more than the appropriate
of the AABB Standards for Blood Banks volume is removed from the donor.
73
Copyright © 2002 by the AABB. All rights reserved.
2. 74 AABB Technical Manual
6. Quality control procedures for sup- senior citizen population in the
plies, reagents, and equipment used donation process. 3 The decision
in donor screening and blood collec- to accept these donors may be
tion.2 made on a case-by-case basis, or
7. A quality assessment and improve- the SOP manual may include
ment program that documents train- general policy statements.
ing and competency testing of staff c. While Standards sets no age lim-
and is designed to monitor critical its for autologous blood collec-
control points in the donor selection tion, each patient must be evalu-
and blood collection processes. If ated to determine if collecting
non-paid, volunteer staff are used, all blood will be safe.
training requirements also apply. 7. A record of reasons for previous defer-
rals, if any.1 Persons who have been
placed on indefinite deferral or sur-
Registration veillance must be identified before
The information obtained from the do- any unit drawn from them is made
nor during registration must fully iden- available for release. Ideally, a donor
tify the donor. Current information deferral registry should be available to
must be obtained and recorded for each identify ineligible donors before blood
donation; single-use or multiple-dona- is drawn. If such a registry is not avail-
tion forms may be used. Donation re- able, there must be a procedure to
cords must be kept indefinitely, and review prior donation records and/or
must make it possible to notify the donor deferral registries before the labeling
of any information that needs to be con- process is completed.4 It may not be
1
veyed. The following information possible to avoid collecting blood
should be included: from unsuitable donors (ie, individu-
1. Date and time of donation. als with repeated reactive tests for vi-
2. Name: Last, first (and middle initial ral agents, needing specified testing
if available). for reentry, or with a medical history
3. Address: Residence and/or business. that would preclude donation) under
4. Telephone: Residence and/or busi- certain circumstances. There must be
ness. a system to prevent the issue of blood
5. Gender. or components from donors whom
6. Age and/or date of birth. Blood do- later testing or records show to be
nors must be at least 17 years of age ineligible.
except that: The following information may also
a. Those who are considered minors be useful:
under applicable law may be ac- 1. Additional identification such as so-
cepted only if written consent to cial security or driver’s license
donate blood has been obtained number or any other name used by
in accordance with the law. Since the donor on a previous donation.
laws vary among jurisdictions, These data are required for informa-
local legal opinion must be ob- tion retrieval in some computerized
tained and a copy of the applica- systems and they provide additional
ble law be readily available. identifying information.
b. Elderly prospective donors may 2. Name of patient or group to be ac-
be accepted at the discretion of knowledged or credited when such a
the blood bank physician. Many system is used. Even if the donor is
blood centers safely involve their deferred, the record may be useful to
Copyright © 2002 by the AABB. All rights reserved.
3. Chapter 4: Donor Selection and Blood Collection 75
those concerned with donor recruit- signs and symptoms associated with hu-
ment or credit accounts. man immunodeficiency virus (HIV) in-
3. Race. This information can be par- fection and AIDS, of high-risk activities
ticularly useful when blood of a spe- for HIV transmission, and of the impor-
cific phenotype is needed for patients tance of refraining from donating blood
who have unexpected antibodies. Care if they have engaged in these activities
should be taken to be sure that minor- or experienced these signs or symptoms.
ity populations understand the medi- The information provided to prospective
cal importance and scientific applica- donors must include a list of activities
tions of this information.5,6 that increase the risk of exposure to HIV.
4. Unique characteristics of the donor. A description of HIV-associated clinical
Certain information about the do- signs and symptoms, including the fol-
7
nor may enable the blood bank to lowing, should be provided :
make optimal use of the donation. 1. Unexplained weight loss.
For example, blood from donors who 2. Night sweats.
are seronegative for cytomega- 3. Blue or purple spots typical of
lovirus (CMV), or who are group O, Kaposi’s sarcoma on or under the
Rh negative, is often designated for skin, or on mucous membranes.
neonatal patients. The blood center 4. Swollen lymph nodes lasting more
may specify that blood from these than 1 month.
individuals be drawn routinely into 5. Persistent white spots or unusual
collection bags suitable for pediatric blemishes in the mouth.
transfusion. Individuals known to 6. Temperature greater than 100.5 F
have clinically significant unex- for more than 10 days.
pected antibodies may be identified 7. Persistent cough and shortness of
so that their blood can be processed breath.
into components that contain only 8. Persistent diarrhea.
minimal amounts of plasma. It is useful to provide information
5. A record of special communications about the tests to be done on the donor’s
to a donor, special drawing of blood blood, the agencies to be notified of abnor-
samples for studies, etc. mal results and the existence of registries
6. If the donation is directed to a spe- of ineligible donors. The possibility that
cific patient, information about testing may fail to identify infective indi-
when and where the intended recipi- viduals in an early, seronegative stage of
ent will be hospitalized should be infection should also be included.8 The
obtained. The intended recipient’s same educational material can also be
date of birth, social security number, used to warn the prospective donor of pos-
or other identifiers may be required sible reactions and provide suggestions for
by the transfusion service. If the do- postphlebotomy care.
nor is a blood relative of the in- It is very important to present this
tended recipient, this must be noted information in a way that the donor will
in the record so that cellular compo- understand. 7 Provisions (eg, interpret-
nents are irradiated. 1 ers) should be made for the hearing- or
vision-impaired. In some locations it
may be necessary to have brochures in
Information Provided to the
more than one language. It is also help-
Prospective Donor ful to provide more detailed information
All donors must be given educational for first-time donors. Information about
materials informing them of the clinical alternative sites or other mechanisms to
Copyright © 2002 by the AABB. All rights reserved.
4. 76 AABB Technical Manual
obtain HIV tests should be available to the donor or if transfusion of the unit
all prospective donors. Prospective do- will harm the recipient. 1,9 The medical
nors must be informed about regula- history questions may be asked by a
tions or local SOPs that require notifica- qualified interviewer or donors may
tion to government agencies of the complete their own record, which must
donors’ HIV status. Prospective donors then be reviewed with the donor and
must also be informed1 if there are cir- initialed by a trained, knowledgeable in-
cumstances in which some tests for dis- dividual responsible to the blood bank.
ease markers are not to be performed. The interview and physical examina-
tion should be performed in a manner
that ensures adequate auditory and vis-
Donor Selection ual privacy, allays apprehensions, and al-
The suitability of donors must be deter- lows time for any necessary discussion
mined by a qualified physician or per- or explanation. Answers to questions
1,9
sons under his/her direction. The do- must be recorded “yes” or “no” and give
nor screening process is one of the most details explaining answers that require
important steps in protecting the safety further investigation. Results of all
of the blood supply. The process is in- physical examination observations and
tended to identify elements of the medi- tests must be recorded.
cal history and behavior or events that
put a person at risk for transmissible
Medical History
disease. It is, therefore, imperative that
proper guidelines and procedures be fol- During the medical history, some very
lowed to make the donor screening proc- specific questions are necessary to en-
ess effective. sure that, to the greatest extent possible,
Donors must understand the infor- it is safe for the donor to donate and for
mation that is presented to them in or- the blood to be transfused. Properly
der to make an informed decision to do- trained staff should question prospective
nate. Effective communication is vital donors about risk behaviors and indicate
for conveying important information whether satisfactory responses are re-
and eliminating unsuitable donors from ceived. The interviewer should evaluate
the donor pool. Of equal importance is all responses to determine suitability for
the training of blood bank staff. Screen- donation, and document the decision. To
ing can only be effective if the staff mem- be sure that all the appropriate questions
bers are proficient in their jobs and un- are asked and that donors are given a
d erst and thoroug hly the technical consistent message, use of the uniform
information required to perform the job. donor medical history questionnaire is
Good interpersonal and public relations recommended. (See Appendix 4-1.) Ap-
skills are essential for job competency. pendix 4-2 lists drugs for which many
Because blood bank staff are in constant blood centers do not require approval
contact with donors, knowledgeable per- from a blood bank physician. Deferring
sonnel and effective communication or rejecting potential donors often leaves
contribute to positive public perception those persons with negative feelings
and help ensure the success of donor about themselves as well as the system.
screening programs. Donor deferral rates should be moni-
Donor selection is based on a medical tored closely by the blood bank physician
history and a limited physical examina- to ensure they are within a reasonable
tion done on the day of donation to de- range. Donors who are deferred should
termine whether giving blood will harm be given a full explanation of the reason
Copyright © 2002 by the AABB. All rights reserved.
5. Chapter 4: Donor Selection and Blood Collection 77
and be informed whether or when they not performed, the donor must be told.
can return. Counseling or referral must be provided
for positive HIV antibody test results.
Since CUE procedures do not pre-
Confidential Unit Exclusion clude donation, an alternate method to
If an opportunity for confidential unit augment self-exclusion may be used. A
exclusion (CUE) is offered, it should be private interview conducted by a trained
provided by a suitably trained person in and competent health-care professional
a setting that ensures strict confidenti- may include oral presentation of the op-
ality and privacy in which to make the tion for self-exclusion, along with AIDS-
decision. All donors must be given the related educational material, and the of-
opportunity to indicate confidentially fer of an opportunity for self-deferral
whether their blood is or is not suitable before the phlebotomy starts. 7
for transfusion to others. CUE may be
accomplished by having a detachable
“ballot” as part of the educational mate-
Physical Examination
rial given the donor. At the time of draw- The following variables must be evaluated
ing, the phlebotomist can attach a bar- for each donor. Exceptions to routinely
coded number to the “ballot” and ask the acceptable findings must be approved by
donor to mark the appropriate response. the blood bank physician. For some cate-
The “ballots” are deposited in a box when gories of nonroutine donors, the medical
the donor leaves the donor room. An- director may provide policies and proce-
other method is to provide the donor dures to guide decisions. Other donors
with a sheet having a bar-coded yes or no may require individual evaluation.
sticker. The donor chooses the desired 1. General appearance: If the donor
sticker and places it on the blood bag or looks ill, appears to be under the
donor card. If the bar-coded response is influence of drugs or alcohol, or is
placed directly on the unit (an ideal lo- excessively nervous, it is best to de-
cation is the area to be covered by the fer the donation. If possible, this
ABO label) the unit of Whole Blood may should be done in a way that does
be scanned and discarded before any fur- not antagonize the donor and, if ap-
ther processing is carried out. There propriate, encourages donation at a
must be a procedure to ensure that no future time.
unit of blood or component is released 2. Weight: Donors weighing 50 kg (110
unless the response to the CUE option is lb) or more ordinarily may donate a
“OK to transfuse.” maximum of 525 mL, including
Alternatively, the donor may be given samples drawn for processing. For
instructions to the effect that he or she donors weighing less than 50 kg
may call the blood bank and ask that the (110 lb), as little as 300 mL may be
unit collected not be used. A mechanism drawn without reducing the amount
should exist to allow retrieval of the unit of anticoagulant in the primary bag.
without obtaining the donor’s identity. Units containing 300-405 mL of
If an opportunity is provided for the blood must be labeled as “Low Vol-
donor to indicate that blood collected ume Unit: _____ mL.” These units
should not be used for transfusion, the should not be used to prepare Plate-
donor should be informed that the blood lets or plasma components. If it is
will be subjected to testing and that there necessary to draw less than 300 mL,
will be notification of any positive results. the amount of anticoagulant must
If, under some circumstances, tests are be reduced proportionately, by ex-
Copyright © 2002 by the AABB. All rights reserved.
6. 78 AABB Technical Manual
Table 4-1. Calculations for Drawing Donors Weighing Less Than 50 kg (110 lb)
A. Volume to draw* = (Donor’s weight in kg/50) × 450 mL
B. Amount of anticoagulant† needed = (A/100) × 14
C. Amount of anticoagulant to remove from collection bag = 63 mL - B
*Approximately 12% of total blood volume
†
CPD or CPDA-1 solutions for which desired anticoagulant:blood ratio is 1.4:10
pressing the excess into an inte- donor is an athlete with high exer-
grally attached satellite bag and cise tolerance, a lower pulse rate
sealing the tubing. The formula in may be acceptable. A blood bank
Table 4-1 may be used to determine physician should evaluate marked
the amount of anticoagulant to re- abnormalities of pulse and recom-
move. The volume of blood drawn mend acceptance, deferral, or refer-
must be measured carefully and ac- ral for additional evaluation.
curately. 5. Blood pressure: The blood pressure
3. Temperature: The donor’s tempera- should be no higher than 180 mm
ture must not exceed 37.5 C (99.5 F) Hg systolic and 100 mm Hg dia-
if measured orally, or its equivalent if stolic. Prospective donors whose
measured by another method. Lower blood pressure is above these values
than normal temperatures are usually should not be drawn without indi-
of no significance in healthy individu- vidual evaluation by a qualified phy-
als. Caution: If a glass thermometer is sician. It may be helpful to define
used, it should not be in the donor’s upper and lower limits in the SOPs.
mouth during puncture to obtain 6. Hemoglobin or packed cell volume
blood for hematocrit or hemoglobin (hematocrit): Before donation, the
determination. The use of thermome- hemoglobin or hematocrit must be
ter covers is advised. determined from a sample of blood
4. Pulse: The pulse rate should be obtained by fingerstick, earlobe punc-
counted for at least 15 seconds. It ture, or venipuncture. Although this
should exhibit no pathologic irregu- screening test is intended to prevent
larity and should be between 50 and collection of blood from a donor with
100 beats per minute. If a prospective anemia, it does not ensure that the
Table 4-2. Minimum Levels of Hemoglobin (Hb) and Hematocrit (Hct) for
Accepting a Blood Donor
Type of Donor Test Method Acceptable Value1
Allogeneic Hb 12.5 g/dL
Hct 38%
Copper sulfate 1.053 (sp gr)
Autologous Hb 11 g/dL
Hct 33%
Copper sulfate 1.049 (sp gr)
Copyright © 2002 by the AABB. All rights reserved.
7. Chapter 4: Donor Selection and Blood Collection 79
donor has an adequate store of iron. surface antigen (HBsAg), HIV-1 antigen,
Table 4-2 gives the lower limits for anti-HIV-1 , or anti-HIV-2]. Abnormali-
accepting allogeneic and autologous ties found before donation may be ex-
donors. Individuals with unusually plained verbally by qualified personnel.
high hemoglobin or hematocrit lev- Test results obtained after donation that
els may need to be evaluated by a preclude further donation may be re-
physician, because elevated levels ported by telephone or letter. Donors
m a y r e f l e c t p u l m o n a r y, h em a- should be asked to report any illness
tologic, or other abnormalities. developing within a few days of donation
Methods to evaluate oxygen-carry- and, especially, to report a positive HIV
ing capacity include specific gravity test or the occurrence of hepatitis or
determined by copper sulfate (see AIDS that develops within 12 months.
Method 9.1), spectrophotometric Written informed consent that allows
measurement of hemoglobin or de- blood bank personnel to collect and use
termination of the hematocrit. blood from the prospective donor is re-
7. Skin lesions: The skin at the site of quired. The consent form is part of the
venipuncture must be free of le- donor record, and must be completed
sions. Both arms must be examined before donation. The procedure must be
for signs of repeated parenteral drug explained in terms that donors can un-
use, especially multiple needle derstand, and there must be an opportu-
puncture marks and/or sclerotic nity for the prospective donor to ask
veins. Evidence of parenteral drug questions and to indicate consent by
abuse is reason for indefinite exclu- signing the form. The signed donor card
sion of a prospective donor. Mild or consent form should also indicate
skin disorders or the rash of poison that the donor has read and understood
ivy should not be cause for deferral the information about infectious dis-
unless unusually extensive and/or eases transmissible by transfusion and
present in the antecubital area. Pro- has given accurate and truthful answers
spective donors who have taken Ac- to the medical history questions. Word-
cutane_ (for acne) within 30 days prior ing equivalent in meaning to the follow-
to donation, or those who have ever ing is suggested:
been treated with Tegison_ (for psoria- “I have reviewed and understand the
sis), must be deferred.1 Individuals information provided to me regard-
with boils, purulent wounds, or severe ing the spread of the AIDS virus (HIV)
skin infections anywhere on the body by blood and plasma. If I am poten-
should be deferred, as should anyone tially at risk for spreading the virus
with purplish-red or hemorrhagic known to cause AIDS, I agree not to
nodules or indurated plaques sugges- donate blood or plasma for transfu-
tive of Kaposi’s sarcoma. sion to another person or for further
The record of physical examination and manufacture. I understand that my
medical history must be identifiable and blood will be tested for HIV and other
contain the examiner’s initials or signa- disease markers. If this testing indi-
ture. Any reasons for deferral must be re- cates that I should no longer donate
corded and explained to the donor. A blood or plasma because of the risk
mechanism must exist to notify the donor of transmitting the AIDS virus, my
of clinically significant abnormal findings name will be entered on a list of per-
in the physical examination, medical his- manently deferred donors. I under-
tory, or postdonation laboratory testing stand that I will be notified of a positive
[especially a positive test for hepatitis B result. If, instead, the results of the
Copyright © 2002 by the AABB. All rights reserved.
8. 80 AABB Technical Manual
testing are not clearly negative or The blood must be processed ac-
positive, my blood will not be used cording to AABB Standards. Special
and my name may be placed on a tags identifying the donor and the
deferral list without my being in- intended recipient must be affixed to
formed until the results are fur- the blood or component bag, and all
ther clarified.” such units must be segregated from
the normal inventory. A protocol for
handling such units must be in-
Special Donor Categories cluded in the SOP manual.
Exceptions to the usual eligibility re- 4. Directed donors: The public’s AIDS-
quirements may be made for special do- related concern about the safety of
nor categories: transfusion has generated demands
1. Autologous donors: The indications from potential recipients to choose
for collection and variations from the donors to be used for their trans-
usual donor procedures are dis- fusions. Several states have laws es-
cussed in Chapter 5. tablishing this as a procedure that
2. H emapheresis: Special require- must be followed in nonemergency
ments and recommendations for situations, if requested by a poten-
cytapheresis donors or for donors in tial blood recipient or ordered by a
a plasmapheresis program are de- physician. Despite logistical and
tailed in Chapter 6. philosophical problems associated
3. Recipient-specific designated dona- with these “directed” donations,
tions: Under certain circumstances, it most blood centers and hospitals
may be important to use blood or provide this service. The selection
components from a specific donor for and testing of directed donors
a specific patient. Examples include should be the same as for other allo-
the patient with an antibody to a high- geneic donors, although special ex-
incidence antigen or a combination of emptions to the 56-day waiting pe-
antibodies that makes it difficult to riod between donations may be
find compatible blood; the infant with made with the blood bank physi-
neonatal thrombocytopenia whose cian’s approval. To avoid misunder-
mother can provide platelets; the pa- standings, it is important to estab-
tient awaiting a kidney transplant lish SOPs that define the time
from a living donor; or the mul- interval required between collection
titransfused patient whose family of the blood and its availability to
members can provide components. the recipient; the policy about deter-
The repeated use of a single donor mining ABO type before collection;
to supply components needed for a and the policy for releasing units for
single patient is allowed, provided it use by other patients.
is requested by the patient’s physi-
cian and approved by the blood bank
physician. The donor must meet all
the usual requirements for dona-
tion, except that the frequency of
Collection of Blood
donation can be as often as every 3 Blood is to be collected only by trained
days, as long as the predonation he- personnel working under the direction
moglobin level meets or exceeds the of a qualified, licensed physician. Blood
minimum value for routine allo- collection must be by aseptic methods,
geneic blood donation. using a sterile, closed system. If more
Copyright © 2002 by the AABB. All rights reserved.
9. Chapter 4: Donor Selection and Blood Collection 81
than one skin puncture is needed, a new Identification
container and donor set must be used for
each additional venipuncture unless the Identification is essential in each step
SOP allows the use of an FDA-approved from donor registration to final disposi-
device to attach a new needle while pre- tion of each component. A numeric or
serving sterility. Whether the phlebot- alphanumeric system must be used that
omy resulted in collection of a full unit, identifies, and relates to, the source do-
the phlebotomist must sign or initial the nor, the donor record, the specimens
donor record. used for testing, the collection con-
tainer, and all components prepared
from the unit. Extreme caution is neces-
Materials and Instruments sary to avoid any mix-up or duplication
of numbers. All cards and labels should
Many items used for phlebotomy are be checked for printing errors prior to
available in sterile, single-use, dispos- use. Duplicate numbers must be dis-
able form. If the package leaks or gets carded. A record must be kept of all
wet, the contents must not be used. voided numbers.
Items such as gauze, cotton balls, appli- Before beginning the collection, the
cators, forceps, and forceps holders may phlebotomist should:
be sterilized adequately by steam under 1. Identify the donor record, at least by
pressure for at least 30 minutes at 121.5 name, with the donor and ask the
C, by dry heat for at least 2 hours at 170 donor to state or spell his/her name.
C or by gas sterilization. Containers of 2. Attach identically numbered labels
bulk-sterilized items should be labeled to the donor record, blood collec-
and dated as to when they were sterilized tion container, attached satellite
and when opened. Unopened sterilized bags, and tubes for donor blood sam-
containers may be stored for up to 3 ples. Attaching the numbers at the
weeks if the container closure ensures donor chair, rather than during the
sterility of the contents. Open contain- examination procedures, helps re-
ers may be used for 1 week if the contents duce the likelihood of identification
are removed using aseptic technique and errors.
lids are replaced. 3. Be sure that the processing tubes
are correctly numbered and that
they accompany the container dur-
Blood Containers ing the collection of blood. Tubes
may be attached in any convenient
Blood must be collected into an FDA-ap-
manner to the primary bag or inte-
proved container that is pyrogen-free
gral tubing.
and sterile, and contains sufficient anti-
4. Recheck all numbers.
coagulant for the quantity of blood to be
collected. The container label must state
the type and amount of anticoagulant,
Preparing Venipuncture Site
and the approximate amount of blood
collected. Blood should be drawn from a large, firm
Blood bags may be supplied in pack- vein in an area (usually the antecubital
ages containing more than one bag. The space) that is free of skin lesions. Both
manufacturer’s directions should be fol- arms must be inspected. A tourniquet or
lowed for the length of time unused bags a blood pressure cuff inflated to 40-60
may be stored in packages that have been mm Hg makes the veins more promi-
opened and resealed. nent. Having the donor open and close
Copyright © 2002 by the AABB. All rights reserved.
10. 82 AABB Technical Manual
the hand a few times is also helpful. Once autologous or uncooperative individ-
the vein is selected, the pressure device ual.11
should be released before the skin site is
prepared.
There is no way to make the venipunc- Care of the Donor After Phlebotomy
ture site completely aseptic, but surgical After removing the needle from the vein,
cleanliness can be achieved to provide the phlebotomist should:
maximal assurance of an uncontaminated 1. Apply firm pressure with sterile
unit. Several acceptable procedures exist. gauze over the point of entry of the
(See Method 9.2.) Occasionally, donors needle into vein. (The donor may be
may be sensitive to the iodine. The SOP instructed to continue application
manual may provide an alternative of pressure for several minutes.)
method, such as hexachlorophene soap Check arm and apply bandage only
scrub followed by acetone- alcohol,10 to after all bleeding stops.
use in this circumstance. After the skin 2. Have donor remain reclining on bed
has been prepared, it must not be touched or in donor chair for a few minutes
again to repalpate the vein. The entire site under close observation by staff.
preparation must be repeated if the 3. Allow the donor to sit up under ob-
cleansed skin is touched. servation when his/her condition
appears satisfactory, and follow the
donor to the observation/refresh-
Phlebotomy and Collection of Samples
ment area. Staff should monitor do-
A technique for drawing a donor unit nors in this area. The period of ob-
and collecting samples for testing ap- s e r v a t i o n an d p r o v i s i o n o f
pears in Method 9.3. The unit should be refreshment should be specified in
collected from a single venipuncture. the SOP manual.
During collection the blood should be 4. Give the donor instructions about
mixed with the anticoagulant. The postphlebotomy care. The medical
amount of blood collected should be director may wish to include some
monitored carefully so the total, includ- or all of the following recommenda-
ing samples, does not exceed 525 mL or tions or instructions:
less for the donor under 50 kg. When the a. Eat and drink something before
appropriate amount has been collected, leaving.
segments and specimen tubes must be b. Do not leave until released by a
filled, and the needle and any blood-con- staff member.
taminated waste disposed of safely. The c. Drink more fluids than usual in
needle must not be recapped; disposal the next 4 hours.
must be in a puncture-proof container. d. Avoid consuming alcohol until
After collection, there must be verifica- you have eaten.
tion that the identifiers on the unit, the e. Do not smoke for 30 minutes.
donor history, and the tubes are the f. If there is bleeding from the phle-
same. botomy site, raise arm and apply
Gloves must be available for use dur- pressure.
ing phlebotomy and must be worn if the g. If fainting or dizziness occurs,
phlebotomist has cuts, scratches, or either lie down or sit with the
other breaks in the skin.11 Gloves must head between the knees.
also be worn by individuals who are in h. If any symptoms persist, either
training as phlebotomists and are re- telephone or return to the blood
quired when collecting blood from an bank or see a doctor.
Copyright © 2002 by the AABB. All rights reserved.
11. Chapter 4: Donor Selection and Blood Collection 83
i. Resume all normal activities if may happen for unexplained reasons.
asymptomatic. Donors who work Whether caused by psychologic factors
in certain occupations (eg, or by neurophysiologic response to
construction workers, operators blood donation, the symptoms may in-
of machinery) or persons work- clude weakness, sweating, dizziness, pal-
ing at heights should be cau- lor, loss of consciousness, convulsions,
tioned that dizziness or faintness and involuntary passage of feces or
may occur if they return to work urine. The skin feels cold and blood pres-
immediately after giving blood. sure falls. Sometimes the systolic levels
j. R em ove bandag e after a few fall as low as 50 mm Hg or cannot be
hours. heard with the stethoscope. The pulse
k. Maintain high fluid intake during rate often slows significantly. This can
the approximately 3 days it takes be useful in distinguishing between va-
for complete restoration of blood sovagal attack and cardiogenic or hypo-
volume. volemic shock, in which cases the pulse
5. Thank the donor for an important rate rises. This distinction, although
contribution and encourage repeat characteristic, is far from absolute.
donation after the proper interval. Deep breathing or hyperventilation
All personnel on duty throughout may cause the anxious or excited donor
the donor area, volunteer or paid, to lose excessive amounts of CO 2. This
should be friendly and qualified to may cause generalized sensations of suf-
observe for signs of impending re- focation or anxiety, or localized prob-
action such as lack of concentra- lems such as tingling or twitching.
tion, pallor, rapid breathing, or ex- The blood bank physician must pro-
cessive perspiration. Donor room vide written instructions for handling
personnel should be competent to donor reactions, including a procedure
interpret instructions and answer for obtaining emergency medical help.
questions, and to accept responsi- Sample instructions might be as fol-
bility for releasing the donor in lows:
good condition. 1. General.
6. Note on the donor record any ad- a. Remove the tourniquet and with-
verse reactions that occurred; if the draw the needle from the arm if
donor leaves the area before being signs of reaction occur during
released, note this on the record. the phlebotomy.
b. If possible, remove any donor
who experiences an adverse reac-
Adverse Donor Reactions tion to an area where he/she can
Most donors tolerate giving blood very be attended in privacy.
well, but occasional adverse reactions c. Apply the measures suggested be-
occur. Personnel must be trained to rec- low and, if these do not lead to
ognize reactions and to provide initial rapid recovery, call the blood
treatment. In many blood banks, donor bank physician or the physician
room personnel are required to have designated for such purposes.
training in cardiopulmonary resuscita- 2. Fainting.
tion (CPR). a. Place the donor on his/her back
Syncope (fainting or vasovagal syn- with feet raised above head.
drome) may be caused by the sight of b. Loosen tight clothing.
blood, by watching others give blood, or c. Be sure the donor has an ade-
by individual or group excitement, or quate airway.
Copyright © 2002 by the AABB. All rights reserved.
12. 84 AABB Technical Manual
d. Apply cold compresses to the do- nel should watch closely for these
nor’s forehead or the back of the symptoms during and immediately
neck. after the phlebotomy.
e. Administer aromatic spirits of a. Divert the donor’s attention by en-
ammonia by inhalation if donor gaging in conversation, to inter-
does not respond to initial meas- rupt the hyperventilation pattern.
ures. Test the ammonia on your- b. Have the donor rebreathe into a
self before passing it under the paper bag if he/she is sympto-
donor’s nose, as it may be too matic. Do not give oxygen.
strong or too weak. Strong am- 5. Hematoma during or after phlebot-
monia may injure the nasal mem- omy.
branes; weak ammonia is not ef- a. Remove the tourniquet and the
f e c t i ve . T h e d o n o r s h o u l d needle from the donor’s arm.
respond by coughing, which ele- b. Place three or four sterile gauze
vates the blood pressure. squares over the venipuncture
f. Monitor blood pressure, pulse, and site and apply firm digital pres-
respiration periodically until the sure for 7-10 minutes with the
donor recovers. donor’s arm held above the heart
Note: Some donors who experi- level. An alternative is to apply a
ence prolonged hypotension may tight bandage, which should be
respond to an infusion of normal removed after 7-10 minutes to al-
saline. The decision to initiate low inspection.
such therapy should be made by c. Apply ice to the area for 5 min-
the blood bank physician either on utes, if desired.
a case-by-case basis or in a policy d. Should an arterial puncture be
stated in the facility SOP manual. suspected, immediately with-
3. Nausea and vomiting. draw needle and apply firm pres-
a. Make the donor as comfortable as sure for 10 minutes. Apply pres-
possible. sure dressing afterwards. Check
b. Instruct the donor who is nause- for the presence of a radial pulse.
ated to breathe slowly and deeply. If pulse is not palpable or is weak,
c. Apply cold compresses to the do- call blood bank physician.
nor’s forehead and/or back of 6. Convulsions.
neck. a. Call for help immediately. Pre-
d. Turn donor’s head to the side. vent the donor from injuring
e. Provide a suitable receptacle if him/herself. During severe sei-
t h e d o n o r v o m i t s, an d h ave zures, some people exhibit great
cleansing tissues or a damp towel muscular power and are difficult
ready. Be sure the donor’s head is to restrain. If possible, hold the
turned to the side because of the donor on the chair or bed; if not
danger of aspiration. possible, place the donor on the
f. After vomiting has ended, give floor. Try to prevent injury to the
the donor some water to rinse out donor and to yourself.
his/her mouth. b. Be sure the donor has an ade-
4. Twitching or muscular spasms. Ex- quate airway.
tremely nervous donors may hyper- c. Notify the blood bank physician.
ventilate, causing faint muscular 7. Serious cardiac difficulties.
twitching or tetanic spasm of their a. Call for medical aid and/or an
hands or face. Donor room person- emergency care unit immediately.
Copyright © 2002 by the AABB. All rights reserved.
13. Chapter 4: Donor Selection and Blood Collection 85
b. If the donor is in cardiac arrest, 5. Beattie KM, Shafer AW. Broadening the base of
a rare donor program by targeting minority
begin CPR immediately and con- populations. Transfusion 1986;26:401-4.
tinue until aid arrives. 6. Vichinsky EP, Earles A, Johnson RA, et al.
The nature and treatment of all reac- Alloimmunization in sickle cell anemia and
tions should be recorded on the donor transfusion of racially unmatched blood. N
record or a special incident report form. Engl J Med 1990;322:1617-21.
7. Food and Drug Administration. Memoran-
This should include a notation as to dum: Revised recommendations for the pre-
whether the donor should be accepted vention of human immunodeficiency virus
for future donations. (HIV) transmission by blood and blood prod-
The medical director should decide ucts. April 23, 1992. Rockville, MD: Congres-
sional and Consumer Affairs, 1992.
what emergency supplies and drugs
8. Centers for Disease Control. Update: Universal
should be in the donor area. The distance precautions for prevention of transmission of
to the nearest emergency room or emer- human immunodeficiency virus, hepatitis B
gency care unit heavily influences deci- virus, and other bloodborne pathogens in
sions about necessary supplies and health-care settings. JAMA 1988;260:528-31.
9. Code of federal regulations, 21 CFR 640.3 (a).
drugs. Most blood banks maintain some Washington, DC: US Government Printing Of-
or all of the following: fice, 1996 (revised annually).
1. Emesis basin or equivalent. 10. Smith LG. Blood collection. In: Green TS,
2. Towels. Steckler D, eds. Donor room policies and pro-
3. Oropharyngeal airway, plastic or cedures. Arlington, VA: American Association
of Blood Banks, 1985:23-7.
hard rubber. 11. C o d e o f f e d e r a l r e g u l a t i o n s , 2 9 C F R
4. Oxygen and mask. 1910.1030. Washington, DC: US Government
5. Emergency drugs: Drugs are seldom Printing Office, 1995 (revised annually).
required to treat a donor who has
had a reaction. If the blood bank
physician wishes to have any drugs
available, the kind and amount to be
kept on hand must be specified in Suggested Reading
writing. In addition, the medical di-
Food and Drug Administration. Memorandum: Ex-
rector must provide written policies emptions to permit persons with a history of viral
as to when and by whom any of the hepatitis before the age of eleven years to serve as
above may be used. donors of Whole Blood and Plasma: Alternate pro-
cedures. April 23, 1992. Rockville, MD: Congres-
sional and Consumer Affairs, 1992.
Food and Drug Administration. Memorandum: Re-
References vised recommendations for the prevention of hu-
man immunodeficiency virus (HIV) transmission
1. Klein HG, ed. Standards for blood banks and
by blood and blood products-section I, parts A & B
transfusion services. 17th ed. Bethesda, MD:
only. December 5, 1990. Rockville, MD: Congres-
American Association of Blood Banks, 1996.
sional and Consumer Affairs, 1990.
2. Code of federal regulations, 21 CFR 606.100
(b). Washington, DC: US Government Printing Holland PV. Why a new standard to prevent
Office, 1996 (revised annually). Creutzfeldt-Jakob disease? Transfusion 1988;
3. Pindyck J, Avorn J, Kuriyan M, et al. Blood 28:293-4.
donation by the elderly. Clinical and policy
considerations. JAMA 1987;257:1186-8. Schmuñis GA. Trypanosoma cruzi, the etiologic
4. Code of federal regulations, 21 CFR 606.160 agent of Chagas’ disease: Status in the blood sup-
(e). Washington, DC: US Government Printing ply in endemic and nonendemic countries. Trans-
Office, 1996 (revised annually). fusion 1991;31:547-57.
Copyright © 2002 by the AABB. All rights reserved.
14. 86 AABB Technical Manual
Appendix 4-1. Uniform Donor History Questionnaire*
Donor History Questions American Association Food and Drug
of Blood Banks (AABB)† Administration (FDA)
A. General
1. Have you ever given No specific requirement. A record shall be available from
blood under a different which unsuitable donors may be
name? identified so that products from
such individuals will not be distrib-
uted. (21 CFR 606.160(e) April
1994)
2. Are you feeling well The prospective donor shall Donor must be determined to be
and healthy today? appear to be in good health. in general good health. (21 CFR
(Standards B2.100) 640.3(b) April 1994)
3. Have you ever been No specific requirement. No specific requirement.
refused as a blood
donor or told not to
donate blood?
4. In the past 4 weeks, Prospective donors who are A donor taking Accutane® or
have you taken any pills, taking medications shall be Proscar® should be deferred from
medications, Accutane® evaluated by a qualified per- donating blood for at least 1
or Proscar®? son to determine suitability month after receipt of the last
to donate blood. (Standards dose. (FDA Memo 7/28/93)1
B1.900)
Have you ever taken A donor who has taken or is tak-
Tegison® for psoriasis? ing Tegison® should be perma-
nently deferred. (FDA Memo
7/28/93)1
5. Unexplained weight The prospective donor shall Donor must be determined to be
loss: Have you lost appear to be in good health. in general good health. (21 CFR
weight recently? (Standards B2.100) 640.3(b) April 1994)
Copyright © 2002 by the AABB. All rights reserved.
15. Chapter 4: Donor Selection and Blood Collection 87
Comments
Since the donor’s name may have changed, noting a previously used name can assist in the
identification of unsuitable donors.
The donor should appear to be in good health. Pain, persistent cough, sore throat, cold or influenza
symptoms, headache, nausea, dizziness or extreme nervousness may be cause for deferral.
Information regarding prior donations and deferrals should be considered when evaluating current
eligibility.
In general, medications taken by a donor are not harmful to the recipient. Most donors taking
medications, even prescription medications, are acceptable blood donors.
Deferral for most drugs is based on the nature of the disease process, not on properties of the
drug itself. This is true of most donors requiring antibiotics, anticonvulsants, anticoagulants,
digitalis, insulin, systemic corticosteroids, vasodilators, and antiarrhythmic or anti-inflammatory
drugs. Isotretinoin (Accutane®), a drug used to treat acne, disqualifies a donor for 1 month, as it
may be a teratogen. For similar reasons, intake of finasteride (Proscar ®), a drug used to treat
benign prostatic hyperplasia, also disqualifies a donor for 1 month after the last dose. Etretinate
(Tegison®), used to treat psoriasis, may be present in the blood for several years after its last use
and its potential teratogenic effects result in the indefinite deferral of the donor.
Use of drugs and medications should be evaluated by a blood bank physician. The approval to
draw these donors may be: 1) a general approval included in the facility SOP manual or 2) an
approval given individually as each problem arises, provided that oral approval is documented on
the donor’s record.
Drugs and medical conditions that are often permitted in blood donors, at the discretion of the
individual facility’s medical director, are listed in Appendix 4-2.
Unexplained weight loss, defined as 10 pounds (4.5 kg) or more, could indicate an undiagnosed
serious illness (including HIV infection), and should be investigated further and evaluated by a
physician.
Copyright © 2002 by the AABB. All rights reserved.
16. 88 AABB Technical Manual
Appendix 4-1. (continued)
Donor History Questions American Association Food and Drug
of Blood Banks (AABB)† Administration (FDA)
B. Questions to protect the donor.
1. In the past 8 weeks, Frequency of blood dona- A person may not serve as a
have you given blood, tion should be not more source of Whole Blood more than
plasma, or platelets? often than every 8 weeks. once in 8 weeks unless otherwise
(Standards B1.300) approved by the medical director.
(21 CFR 640.3(f) April 1994)
2. In the past 12 Prospective donors who Persons who have received a
months, have you been during the preceding 12 transfusion of Whole Blood or a
under a doctor’s care or months received blood or blood component within the past
had a major illness or derivatives known to be 12 months should not donate
surgery? sources of hepatitis shall be blood or blood components. (FDA
excluded. (Standards Memo 4/23/92)2
B2.420)
3. Have you ever had Prospective donors with dis- Donor must be free of acute respi-
chest pain, heart eases of the heart or lungs ratory disease. (21 CFR
disease, or lung disease? shall be excluded subject to 640.3(b)(4) April 1994)
evaluation by a qualified
physician. (Standards
B1.700)
4. Have you ever had Prospective donors with a Persons with hemophilia or re-
cancer, a blood disease, history of cancer or abnor- lated clotting disorders who have
or a bleeding problem? mal bleeding tendency shall received clotting factor concen-
be excluded unless deter- trates must not donate blood or
mined to be suitable to do- blood components. (FDA Memo
nate by a qualified physi- 4/23/92)2
cian. (Standards B1.700)
5. Female Donors: In the Existing pregnancy or preg- No specific requirement.
past 6 weeks, have you nancy in past 6 weeks shall
been pregnant or are preclude routine donation.
you pregnant now? (Standards B1.800)
Copyright © 2002 by the AABB. All rights reserved.
17. Chapter 4: Donor Selection and Blood Collection 89
Comments
Donors should not be bled of more than 525 mL of whole blood within an 8-week period. In
unusual circumstances more frequent donation is permissible with the written permission of the
blood bank physician after examination. At least 48 hours must elapse before whole blood
donation for individuals who have undergone hemapheresis. At the request of the recipient’s
physician, and with the approval of a blood bank physician, consenting individuals may donate
more frequently if they are in a program to provide components from a single donor for a specific
recipient. In such cases, except for donation interval, the donors must meet all the usual criteria
for allogeneic donors.
Donors who have undergone operations should be deferred for at least 12 months if they received
blood components or derivatives known to transmit disease. Uncomplicated surgery is disquali-
fying only until healing is complete and full activity has been resumed. Questionable answers that
might indicate the donor is not in good health should be referred to a blood bank physician for
further evaluation.
A history of heart disease that may result in acute heart failure associated with the blood donation
is cause for deferral, unless evaluated and approved by the blood bank physician.
Active pulmonary tuberculosis, or any active pulmonary disease, is cause for deferral. Previous
tuberculosis, successfully treated and no longer active, need not disqualify a donor. Donors with
a history of a reactive tuberculin skin test may be accepted provided they are not under treatment
or receiving prophylactic therapy.
Prospective donors who have had cancer, other than localized skin cancer or carcinoma-in-situ
of the cervix, should be evaluated by a qualified physician before being accepted as a blood donor.
Individuals who have definitive therapy and are free of disease for at least 5 years may be
acceptable donors. Donors who have or have had leukemia or lymphoma must be permanently
deferred. If the donor has another blood disease, it should be evaluated by the blood bank
physician.
An abnormal bleeding tendency may be cause for deferral subject to evaluation by the blood
bank physician. Individuals with such a history may experience excessive bleeding at the site of
venipuncture and require special care following donation.
Defer donors during pregnancy and for 6 weeks following conclusion of pregnancy. Exceptions
may be made by a blood bank physician if the woman’s blood is intended for transfusion to her
infant. Pregnancy is not an absolute contraindication for autologous collection (see Chapter 5).
Copyright © 2002 by the AABB. All rights reserved.
18. 90 AABB Technical Manual
Appendix 4-1. (continued)
Donor History Questions American Association Food and Drug
of Blood Banks (AABB)† Administration (FDA)
C. Questions to protect the recipient
1. In the past 3 days, Ingestion of aspirin or other No specific requirement for whole
have you taken aspirin, medications that inhibit blood donation. Donors who have
or anything that has platelet function and have a recently taken medication contain-
aspirin in it? prolonged half-life within 3 ing aspirin, especially within 36
days precludes use of do- hours, may not be suitable donors
nor as sole source of Plate- for Platelets, Pheresis. (FDA
lets. (Standards B2.500) Guidelines 10/7/88)3
2. Have you ever had Prospective donors with dis- No individual with a history of
yellow jaundice, liver eases of the liver shall be hepatitis shall be source of whole
disease, hepatitis, or a excluded subject to evalu- blood donation. (21 CFR 640.3(c)
positive test for ation by a qualified physi- April 1994)
hepatitis? cian. (Standards B1.700)
Donors with a history of Exceptions for history of hepatitis
hepatitis after their 11th before age 11. (FDA Memo
birthday or a confirmed test 4/23/92)4
for HBsAg are indefinitely
deferred. (Standards
B2.711)
Copyright © 2002 by the AABB. All rights reserved.
19. Chapter 4: Donor Selection and Blood Collection 91
Comments
Compounds containing aspirin or other medications that inhibit platelet function and have a
prolonged half-life depress platelet function for 1-5 days. Platelets from a donor who has taken
aspirin within 3 days should not be the only source of Platelets for a patient.
A hepatitis carrier status cannot be detected with certainty by laboratory tests such as HBsAg,
anti-HCV, and anti-HBc. Therefore, strict guidelines for donor acceptability must be established
and followed. Defer indefinitely prospective donors who:
a. Have a history of viral hepatitis after their 11th birthday. (Note: In 21 CFR 640.3(c)(1) and
640.63(c)(11) no age is specified in the requirement to reject donors with a history of
hepatitis; however, the FDA’s Center for Biologics Evaluation and Research has issued a
memorandum indicating that individuals with a history of viral hepatitis prior to age 11 are
acceptable as donors of Whole Blood and Source Plasma.) An active inflammatory or chronic
disease of the liver or one that might impair organ function is cause for deferral of the donor.
Liver inflammation associated with well-documented infectious mononucleosis, CMV infec-
tion, or use of a therapeutic drug is not a cause for permanent deferral.
b. Have a history of hepatitis B or a confirmed positive test for HBsAg or who have had a
repeatedly reactive test for anti-HBc on two or more occasions.
c. Have present or past clinical or laboratory evidence of infection with hepatitis C.
d. Have used intravenous drugs. Inspect both arms for evidence of repeated IV access for
injection of drugs.
e. Have donated the only unit of blood or blood component transfused to a patient who developed
clinical or laboratory evidence of transfusion-associated hepatitis and who received no other
blood component or derivative known to transmit hepatitis and had no other probable cause
of infection.
f. Whose involvement in two or more transfusion-associated hepatitis cases results in a
cumulative probability value greater than 0.4 (see Chapter 26).
Defer for 12 months:
a. Recipients of blood, blood components, or clotting factor concentrate. This includes donors
who are in blood immunization programs. Receipt of other FDA-licensed plasma derivatives
such as albumin or immunoglobulins does not specifically require a deferral.
b. Donors who share living quarters or are a sexual partner of a person with viral hepatitis.
Copyright © 2002 by the AABB. All rights reserved.
20. 92 AABB Technical Manual
Appendix 4-1. (continued)
Donor History Questions American Association Food and Drug
of Blood Banks (AABB)† Administration (FDA)
3. In the past 12 Prospective donors shall be Persons who have had any con-
months, have you had a deferred from donating tact with blood and body fluids
tattoo, ear or skin blood or blood components through percutaneous inoculation
piercing, acupuncture, for transfusion who, within (such as injury or accidental
accidental needlestick, the preceding 12 months, needlestick) or through contact
or come in contact with have a history of: 1) a tat- with an open wound, nonintact
someone else’s blood? too; 2) mucous membrane skin, or mucous membrane dur-
exposure to blood; 3) non- ing the preceding 12 months
sterile skin penetration with should be deferred. (FDA Memo
instruments or equipment 4/23/92)2
contaminated with blood or
body fluids; 4) sexual or
household contact with an
individual with viral hepati-
tis; 5) sexual contact with
an individual with HIV or at
high risk of HIV infection.
(Standards B2.721, B2.722,
B2.723, B2.724, B2.725)
4. In the past 12 Sexual or household con- Close contact with person who
months, have you had tact with a person who has has viral hepatitis shall result in
close contact with a viral hepatitis is cause for 12-month deferral. (FDA Memo
person with yellow 12-month deferral. (Stand- 4/23/92)5
jaundice or hepatitis, or ards B2.724)
have you been given
Hepatitis B Immune
Globulin (HBIG)?
5. In the past 12 History of blood transfu- Persons who have received a
months, have you sion is cause for 12-month transfusion of Whole Blood or a
received blood or had an deferral. (Standards B2.420) blood component within the past
organ or tissue 12 months should not donate
transplant? blood or blood components. (FDA
Memo 4/23/92)2
Copyright © 2002 by the AABB. All rights reserved.
21. Chapter 4: Donor Selection and Blood Collection 93
Comments
Donors should be questioned about ear piercing, skin piercing, electrolysis, and acupuncture to
make sure that single-use equipment, disposables, or properly sterilized needles were used.
Health-care workers should be carefully evaluated to determine if they have had a needlestick
injury or other type of percutaneous or mucosal exposure to patient’s blood or an unknown source.
Exposure to another person’s blood through broken skin or intact mucosal surface is cause for
12-month deferral from the time the exposure occurred.
The type of contact that hospital personnel and physicians encounter may not be cause per se for
deferral. Donors who had unprotected or accidental exposure to blood and body fluids in a
health-care setting or other job should be deferred. Percutaneous exposures (ie, needlesticks or
mucous membrane splashes of potentially infectious materials) should result in donor deferral.
Note: feces, nasal secretions, sputum, sweat, tears, urine, or vomitus are not known to be
infectious for HIV or HBV unless visibly contaminated with blood. Defer for 12 months prospective
donors in the following categories:
a. Persons who underwent ear piercing, skin piercing, depilation, or acupuncture where the
sterility of the equipment used cannot be verified.
b. Individuals who have been incarcerated in a correctional institution for more than 72 consecu-
tive hours since the likelihood of exposure to transfusion-transmissible agents is very high.
c. Persons who have received HBIG, since this is given only to individuals with especially close
contact with hepatitis B. HBIG may prolong the incubation period of hepatitis B beyond the
usual 6-month period.
d. Persons who share living quarters or are a sexual partner of someone with viral hepatitis.
Persons who have received allografts from those tissue or tissue derivatives known to be possible
sources of the Creutzfeldt-Jakob agent must be indefinitely deferred from blood donation. Persons
who have received a transfusion of Whole Blood or a blood component, or other tissue allografts
within the past 12 months, should not donate blood or blood components.
Copyright © 2002 by the AABB. All rights reserved.
22. 94 AABB Technical Manual
Appendix 4-1. (continued)
Donor History Questions American Association Food and Drug
of Blood Banks (AABB)† Administration (FDA)
6. In the past 3 years, Travelers who have been in Donor must be free of any disease
have you been outside an area considered endemic transmissible by blood transfu-
the US or Canada? for malaria may be ac- sion based on history and exami-
cepted as regular blood do- nations. (21 CFR 640.3(b)(6) April
nors 1 year after return irre- 1994)
spective of the receipt of
antimalarial prophylaxis.
(Standards B2.743) Immi-
grants, refugees or citizens
coming from a country con-
sidered endemic for malaria
may be accepted as blood
donors 3 years after depar-
ture from endemic area.
(Standards B2.742)
7. Have you ever had Prospective donors who Donors must be free of any dis-
malaria, Chagas’ have had a diagnosis of ma- ease transmissible by blood trans-
disease, or babesiosis? laria shall be deferred for 3 fusion based on history and ex-
years. (Standards B2.741) aminations. (21 CFR 640.3(b)(6)
A history of babesiosis or April 1994)
Chagas’ disease shall be
cause for indefinite deferral.
(Standards B2.750)
8.A. Have you ever been Individuals who have re- The FDA recommends that any do-
given growth hormone? ceived pituitary growth hor- nor who has received injections of
mone of human origin must pit-hGH be permanently deferred.
not be accepted for dona- (FDA Memo 7/28/93)1
tion of blood, tissue, or or-
gans. (Standards B2.410)
8.B. Have you ever had Prospective donors who The FDA recommends that per-
head or brain surgery have a family history of sons who have received trans-
with a transplant of Creutzfeldt-Jakob disease plants for dura mater be perma-
brain covering (dura or who have received tissue nently deferred from donation.
mater)? or tissue derivatives known (FDA Memo 8/8/95)6
to be a possible source of
the Creutzfeldt-Jakob agent
shall be indefinitely de-
ferred. (Standards B2.410)
8.C. Have you or any of The FDA recommends that per-
your relatives ever had a sons with a family history of
disease called Creutzfeldt-Jakob disease be per-
Creutzfeldt-Jakob manently deferred from donation
disease (CJD)? unless increased risk is excluded
based on specialized testing. (FDA
Memo 8/8/95)6
Copyright © 2002 by the AABB. All rights reserved.
23. Chapter 4: Donor Selection and Blood Collection 95
Comments
Travelers who have been in areas in which malaria is considered endemic by the Malaria Program,
Centers for Disease Control and Prevention (CDC), US Department of Health and Human Services,
may be accepted as regular blood donors 1 year after return to the nonendemic area, provided
they have been free of unexplained febrile illnesses. The CDC’s “Health Information for Interna-
tional Travel” [HHS Publication No. (CDC) 92-8280] should be available to the interviewing
personnel to determine which areas are considered endemic.
It is helpful to have a recent world map available to personnel interviewing donors to locate
areas where travelers or immigrants have been.
Immigrants, refugees, citizens, or residents coming from an area in which malaria is endemic
must be deferred for 3 years after departure from the malarial area, if they have been asymptomatic
in the interim. Donations from which only the plasma will be used are exempt from these
restrictions.
Donors with a history of disease caused by either Babesia species or Trypanosoma cruzi must be
indefinitely deferred. Persons who originate from Latin America, especially rural areas, may have
T. cruzi infection without evidence of acute symptoms in the past. More detailed follow-up
questions as to the exact circumstances of possible exposure to these diseases may be necessary.
From 1958-1986 pit-hGH was used to treat children of short stature and by some individuals
during rigorous physical training. Several cases of Creutzfeldt-Jakob disease (CJD) have been
reported in persons given pit-hGH. Since the agent causing this disease might be transmissible
by transfusion, donors who have received pit-hGH must be indefinitely deferred. Deferral is not
necessary if the donor has only been given recombinant-derived growth hormone.
Although there is no evidence that the CJD agent is transmitted by blood transfusion, it can be
transmitted by brain tissue or membranes.
Familial Creutzfeldt-Jakob disease (CJD) has been described.
Copyright © 2002 by the AABB. All rights reserved.
24. 96 AABB Technical Manual
Appendix 4-1. (continued)
Donor History Questions American Association Food and Drug
of Blood Banks (AABB)† Administration (FDA)
9. In the past 4 weeks, Donors must be queried No specific requirement.
have you had any shots about vaccines and immuni-
or vaccinations? zations. (Standards B2.600)
10. In the past 12 Donor is deferred for 12 No specific requirement.
months, have you been months after vaccine treat-
given rabies shots? ment for bite. (Standards
B2.620)
11. A. In the past 12 A history of syphilis or gon- Persons who have had, or have been
months, have you had a orrhea, or treatment for treated for, syphilis or gonorrhea
positive test for syphilis? either, shall be cause for de- during the preceding 12 months
11. B. In the past 12 ferral for 12 months after should not donate blood or blood
months, have you had or completion of therapy. components. Persons with a posi-
been treated for syphilis (Standards B2.340) tive (STS) test should be deferred 12
or gonorrhea? months. (FDA Memo 12/12/91)7
12. In the past 12 Donor must be given educa- Men and women who have en-
months, have you given tional material on AIDS gaged in sex for money or drugs
money or drugs to anyone high-risk activity, and such since 1977 and persons who have
to have sex with you? At at-risk persons should re- engaged in sex with such people
any time since 1977, have frain from donating blood. during the preceding 12 months
you taken money or drugs (Standards B2.730 and should not donate blood or blood
for sex? In the past 12 B3.100) components. (FDA Memo
months, have you had 4/23/92)2
sex, even once, with
anyone who has had sex
for drugs or money?
13. A. Have you ever A. Evidence of narcotic ha- A. Donor must be free from skin
used a needle, even bituation is cause for indefi- punctures or scars indicative of ad-
once, to take any drug nite deferral. (Standards diction to self-injected narcotics. (21
(including steroids)? B2.330) CFR 640.3(b)(7) April 1994) Past or
13. B. In the past 12 B. Refer to question #12. present intravenous drug users
months, have you had should not donate blood or blood
sex, even once, with components. (FDA Memo 4/23/92)2
anyone who has used a B. Persons who have had sex with
needle to inject drugs? any person who is a past or present
intravenous drug user should not do-
nate blood or blood components for
12 months. (FDA Memo 4/23/92)2
Copyright © 2002 by the AABB. All rights reserved.
25. Chapter 4: Donor Selection and Blood Collection 97
Comments
a. Symptom-free donors who have been immunized with toxoids or killed vaccines need not be
deferred. Included in this group of immunizations are those for anthrax, cholera, diphtheria,
influenza, paratyphoid, pertussis, plague, polio (injection, Salk), Rocky Mountain spotted
fever, tetanus, typhoid, and typhus.
b. Measles (rubeola), mumps, yellow fever, oral polio vaccine (Sabin): Donors are acceptable 2
weeks after their last immunization.
c. German measles (rubella): Donors are acceptable 4 weeks after their last immunization.
d. Hepatitis B and Hepatitis A vaccines: Prospective donors are acceptable provided they would
not otherwise be disqualified.
e. Immune serum globulin: Defer if HBIG was given in last 12 months. If donor has been given
IVIG, defer based on underlying condition. Otherwise acceptable.
If possible exposure to a rabid animal occurred, defer for 1 year.
Persons with a history of acute disease or treatment for syphilis or gonorrhea in the preceding
12 months must be deferred.
Men and women who have engaged in sex for money or drugs since 1977 and persons who have
engaged in sex with such people during the preceding 12 months should not donate blood or
blood components.
Use of intravenous drugs under nonsterile conditions puts a person at high risk for infection with
HIV, hepatitis, HTLV-I or II, as well as other transmissible disease agents. Because of the
propensity of repeat behavior associated with the use of addictive drugs, users of intravenous
drugs are deferred indefinitely. Their sexual partners are deferred for 12 months after the last
sexual contact, even if “safer sex” practices were followed.
Self-injection of insulin preparations as well as regular “allergy shots” are not cause for deferral.
However, parenteral use of medication not prescribed by a physician is reason for indefinite
deferral.
Copyright © 2002 by the AABB. All rights reserved.
26. 98 AABB Technical Manual
Appendix 4-1. (continued)
Donor History Questions American Association Food and Drug
of Blood Banks (AABB)† Administration (FDA)
14. Male donors: Have Refer to question #12. Men who have had sex with an-
you had sex with other man even one time since
another male, even once 1977 should not donate blood or
since 1977? blood components permanently.
Female Donors: In the Females who have had sex with
past 12 months, have men who have had sex with an-
you had sex with a male other man even one time since
who has had sex, even 1977 should not donate blood or
once since 1977, with blood components for 12 months.
another male? (FDA Memo 4/23/92)2
15. A. Have you ever No specific requirement. A. Persons with hemophilia or re-
taken clotting factor lated clotting disorders who have
concentrates for a received clotting factor concen-
bleeding problem, such trates should not donate blood or
as hemophilia? blood components. (FDA Memo
4/23/92)2
15. B. In the past 12 B. Persons who have had sex with
months, have you had any person with hemophilia or re-
sex, even once, with lated clotting disorders who have
anyone who has received clotting factor concen-
received a clotting factor trates should not donate blood or
concentrate? blood components for 12 months.
(FDA Memo 4/23/92)2
16. A. Do you have AIDS Refer to question #12. A. Persons with clinical or labora-
or have you had a tory evidence of HIV infection
positive test for the must not donate blood or blood
AIDS virus? components. (FDA Memo
4/23/92)2
16. B. In the past 12 B. Persons who have had sex with
months, have you had persons with clinical or laboratory
sex, even once, with evidence of HIV infection should
anyone who has? not donate blood or blood compo-
nents for 12 months. (FDA Memo
4/23/92)2
17. Are you giving blood No specific requirement. No specific requirement.
so that you will be
tested for AIDS?
18. Do you understand No specific requirement. Donors should be informed that
that if you have the AIDS there is an interval during early in-
virus, you can give it to fection when the HIV tests may be
someone else even negative although the infection
though you may feel may still be transmitted. (FDA
well and have a negative Memo 4/23/92)2
AIDS test?
Copyright © 2002 by the AABB. All rights reserved.
27. Chapter 4: Donor Selection and Blood Collection 99
Comments
Men who have had sex with another man even one time since 1977 should not donate blood or
blood components. Females who have had sex with men who have had sex with another man even
one time since 1977, should not donate blood or blood components for 12 months.
Individuals who have been treated with factor concentrates are at high risk of exposure to
transmissible disease agents and must be deferred indefinitely. Their sexual partners must be
deferred for 12 months after the last sexual contact, even if “safer sex” practices were followed.
Persons with clinical or laboratory evidence of HIV infection must not donate blood or blood
components. Persons who have had sex with persons with clinical or laboratory evidence of HIV
infection should not donate blood or blood components for 12 months.
Due to the possibility of donation during the seronegative “window” period of infection, individuals
must be strongly discouraged from donating blood just to get tested for HIV. Alternative site testing
should be offered to individuals who wish to obtain HIV test results.
Donors should be informed that there is a time early after exposure to HIV during which the tests
for HIV, done on all donations, may not detect infection. Information should be provided about
donor deferral registries. Persons who are not suitable as donors but desire to learn their test
status should be given instructions about alternate mechanisms to obtain testing.
Copyright © 2002 by the AABB. All rights reserved.
28. 100 AABB Technical Manual
Appendix 4-1. (continued)
Donor History Questions American Association Food and Drug
of Blood Banks (AABB)† Administration (FDA)
19. Have you read and No specific requirement. Information should be written in
understood all the donor language that ensures that the do-
information presented to nor understands the definition of
you, and have all your high-risk behavior and the impor-
questions been tance of self-exclusion. Donors
answered? should not be considered suitable
unless information about risks
can be communicated in the lan-
guage appropriate to each donor
and is constructed to be culturally
sensitive to promote comprehen-
sion. (FDA Memo 4/23/92)2
References
1. FDA Memorandum, July 28, 1993: Deferral of Blood and Plasma Donors Based on Medica-
tions.
2. FDA Memorandum, April 23, 1992: Revised Recommendations for the Prevention of HIV
Transmission by Blood and Blood Products.
3. FDA Memorandum, October 7, 1988: Revised Guideline for the Collection of Platelets,
Pheresis.
4. FDA Memorandum, April 23, 1992: Exemptions to Permit Persons With a History of Viral
Hepatitis Before the Age of 11 Years to Serve as Donors of Whole Blood and Plasma:
Alternative Procedures, 21 CFR 640.120.
5. FDA Memorandum, April 23, 1992: Revised Recommendations for Testing Whole Blood, Blood
Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus
Encoded Antigen (Anti-HCV).
6. FDA Memorandum, August 8, 1995: Precautionary Measures to Further Reduce the Possible
Risks of Transmission of Creutzfeldt-Jakob Disease by Blood and Blood Products.
7. FDA Memorandum, December 12, 1991: Clarification of FDA Recommendations for Donor
Deferral and Product Distribution Based on the Results of Syphilis Testing.
*
This donor history questionnaire uses the June 2, 1995 version, which was approved by the
FDA. It has been updated with correct numbering of the Standards, 17th edition, the Creutzfeldt-
Jakob Disease (CJD) questions (effective November 30, 1995 with Association Bulletin #95-8),
and expanded comments from the Technical Manual Committee. This updated version has not
been approved by the FDA at time of publication.
†
Standards referred to are from the 17th edition of Standards for Blood Banks and Transfusion
Services, effective June 1, 1996.
Copyright © 2002 by the AABB. All rights reserved.
29. Chapter 4: Donor Selection and Blood Collection 101
Comments
Donors must be given educational material informing them of high-risk activities for AIDS and the
necessity of refraining from donating blood if at risk. All donors must be asked if they have read
and understood the educational material informing potential donors that persons at increased risk
of AIDS should refrain from donating blood.
Copyright © 2002 by the AABB. All rights reserved.
30. 102 AABB Technical Manual
Appendix 4-2. Some Drugs Commonly Accepted in Blood Donors
In many blood centers, blood donation may be allowed by individuals who have taken the following
drugs:
s Tetracyclines and other antibiotics taken to treat acne.
s Topical steroid preparations for skin lesions not at the venipuncture site.
s Blood pressure medications, taken chronically and successfully so that pressure is at or below
allowable limits. The prospective donor taking antihypertensive drugs should be free from side
effects, especially episodes of postural hypotension, and should be free of any cardiovascular
symptoms.
s Over-the-counter bronchodilators and decongestants.
s Oral hypoglycemic agents in well-controlled diabetics without any vascular complications of
the disease.
s Tranquilizers, under most conditions. A physician should evaluate the donor to distinguish
between tranquilizers and antipsychotic medications.
s Hypnotics used at bedtime.
s Marijuana (unless currently under the influence), oral contraceptives, mild analgesics, vita-
mins, replacement hormones, or weight reduction pills.
Note: Acceptance of donors must always be with the approval of the blood bank’s medical
director.
Copyright © 2002 by the AABB. All rights reserved.