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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

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Taller Banco de Sangre - Seleccion donantes

  • 1. 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.