Taller Banco de Sangre - Seleccion donantes


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Taller Banco de Sangre - Seleccion donantes

  1. 1. 4 Donor Selection and Blood Collection B l o o d c e n t e r s an dtransfusion 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 andthey serve. To attract volunteer donors must be reviewed at least annually by ainitially 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 beas 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 toBlood Donation Process qualify donors, including mini-The donor area should be attractive and mum and maximum acceptableopen at hours convenient for donors, values and the policies and proce-and must be well-lighted, comfortably dures governing qualifications ofventilated, 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 thedetailing 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 ensureprocedures must meet the requirements that no more than the appropriateof the AABB Standards for Blood Banks volume is removed from the donor. 73 Copyright © 2002 by the AABB. All rights reserved.
  2. 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 beforeThe information obtained from the do- any unit drawn from them is madenor during registration must fully iden- available for release. Ideally, a donortify the donor. Current information deferral registry should be available tomust be obtained and recorded for each identify ineligible donors before blooddonation; 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 tocords must be kept indefinitely, and review prior donation records and/ormust make it possible to notify the donor deferral registries before the labelingof any information that needs to be con- process is completed.4 It may not be 1veyed. The following information possible to avoid collecting bloodshould 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. 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 inInformation Provided to the more than one language. It is also help-Prospective Donor ful to provide more detailed informationAll donors must be given educational for first-time donors. Information aboutmaterials informing them of the clinical alternative sites or other mechanisms to Copyright © 2002 by the AABB. All rights reserved.
  4. 4. 76 AABB Technical Manualobtain HIV tests should be available to the donor or if transfusion of the unitall prospective donors. Prospective do- will harm the recipient. 1,9 The medicalnors must be informed about regula- history questions may be asked by ations or local SOPs that require notifica- qualified interviewer or donors maytion to government agencies of the complete their own record, which mustdonors’ HIV status. Prospective donors then be reviewed with the donor andmust 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 discussionmined by a qualified physician or per- or explanation. Answers to questions 1,9sons under his/her direction. The do- must be recorded “yes” or “no” and givenor screening process is one of the most details explaining answers that requireimportant steps in protecting the safety further investigation. Results of allof the blood supply. The process is in- physical examination observations andtended to identify elements of the medi- tests must be recorded.cal history and behavior or events thatput a person at risk for transmissible Medical Historydisease. It is, therefore, imperative thatproper guidelines and procedures be fol- During the medical history, some verylowed 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 formation that is presented to them in or- the blood to be transfused. Properlyder to make an informed decision to do- trained staff should question prospectivenate. Effective communication is vital donors about risk behaviors and indicatefor conveying important information whether satisfactory responses are re-and eliminating unsuitable donors from ceived. The interviewer should evaluatethe donor pool. Of equal importance is all responses to determine suitability forthe training of blood bank staff. Screen- donation, and document the decision. Toing can only be effective if the staff mem- be sure that all the appropriate questionsbers are proficient in their jobs and un- are asked and that donors are given ad erst and thoroug hly the technical consistent message, use of the uniforminformation required to perform the job. donor medical history questionnaire isGood interpersonal and public relations recommended. (See Appendix 4-1.) Ap-skills are essential for job competency. pendix 4-2 lists drugs for which manyBecause blood bank staff are in constant blood centers do not require approvalcontact with donors, knowledgeable per- from a blood bank physician. Deferringsonnel and effective communication or rejecting potential donors often leavescontribute to positive public perception those persons with negative feelingsand 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 physicianhistory and a limited physical examina- to ensure they are within a reasonabletion done on the day of donation to de- range. Donors who are deferred shouldtermine whether giving blood will harm be given a full explanation of the reason Copyright © 2002 by the AABB. All rights reserved.
  5. 5. Chapter 4: Donor Selection and Blood Collection 77and 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 toIf an opportunity for confidential unit augment self-exclusion may be used. Aexclusion (CUE) is offered, it should be private interview conducted by a trainedprovided by a suitably trained person in and competent health-care professionala 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-deferralwhether their blood is or is not suitable before the phlebotomy starts. 7for transfusion to others. CUE may beaccomplished by having a detachable“ballot” as part of the educational mate- Physical Examinationrial given the donor. At the time of draw- The following variables must be evaluateding, the phlebotomist can attach a bar- for each donor. Exceptions to routinelycoded number to the “ballot” and ask the acceptable findings must be approved bydonor 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 medicalthe donor leaves the donor room. An- director may provide policies and proce-other method is to provide the donor dures to guide decisions. Other donorswith a sheet having a bar-coded yes or no may require individual evaluation.sticker. The donor chooses the desired 1. General appearance: If the donorsticker and places it on the blood bag or looks ill, appears to be under thedonor card. If the bar-coded response is influence of drugs or alcohol, or isplaced 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, thisABO label) the unit of Whole Blood may should be done in a way that doesbe scanned and discarded before any fur- not antagonize the donor and, if ap-ther processing is carried out. There propriate, encourages donation at amust be a procedure to ensure that no future time.unit of blood or component is released 2. Weight: Donors weighing 50 kg (110unless 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. Forinstructions to the effect that he or she donors weighing less than 50 kgmay call the blood bank and ask that the (110 lb), as little as 300 mL may beunit collected not be used. A mechanism drawn without reducing the amountshould 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 unitsshould 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 iswill 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 mustIf, under some circumstances, tests are be reduced proportionately, by ex- Copyright © 2002 by the AABB. All rights reserved.
  6. 6. 78 AABB Technical ManualTable 4-1. Calculations for Drawing Donors Weighing Less Than 50 kg (110 lb)A. Volume to draw* = (Donor’s weight in kg/50) × 450 mLB. Amount of anticoagulant† needed = (A/100) × 14C. 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 pressure3. 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 blood4. 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 theTable 4-2. Minimum Levels of Hemoglobin (Hb) and Hematocrit (Hct) forAccepting a Blood DonorType of Donor Test Method Acceptable Value1Allogeneic 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. 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 mymedical history must be identifiable and blood will be tested for HIV and othercontain 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 donatecorded and explained to the donor. A blood or plasma because of the riskmechanism must exist to notify the donor of transmitting the AIDS virus, myof 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. 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 ofnor 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. 9. Chapter 4: Donor Selection and Blood Collection 81than one skin puncture is needed, a new Identificationcontainer and donor set must be used foreach additional venipuncture unless the Identification is essential in each stepSOP 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 orserving sterility. Whether the phlebot- alphanumeric system must be used thatomy 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 specimensdonor 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 shouldMany items used for phlebotomy are be checked for printing errors prior toavailable 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 allwet, the contents must not be used. voided numbers.Items such as gauze, cotton balls, appli- Before beginning the collection, thecators, forceps, and forceps holders may phlebotomist should:be sterilized adequately by steam under 1. Identify the donor record, at least bypressure for at least 30 minutes at 121.5 name, with the donor and ask theC, 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 labelsbulk-sterilized items should be labeled to the donor record, blood collec-and dated as to when they were sterilized tion container, attached satelliteand when opened. Unopened sterilized bags, and tubes for donor blood sam-containers may be stored for up to 3 ples. Attaching the numbers at theweeks if the container closure ensures donor chair, rather than during thesterility of the contents. Open contain- examination procedures, helps re-ers may be used for 1 week if the contents duce the likelihood of identificationare 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 convenientBlood 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 becollected. The container label must statethe type and amount of anticoagulant, Preparing Venipuncture Siteand the approximate amount of bloodcollected. Blood should be drawn from a large, firm Blood bags may be supplied in pack- vein in an area (usually the antecubitalages containing more than one bag. The space) that is free of skin lesions. Bothmanufacturer’s directions should be fol- arms must be inspected. A tourniquet orlowed for the length of time unused bags a blood pressure cuff inflated to 40-60may 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. 10. 82 AABB Technical Manualthe hand a few times is also helpful. Once autologous or uncooperative individ-the vein is selected, the pressure device ual.11should be released before the skin site isprepared. There is no way to make the venipunc- Care of the Donor After Phlebotomyture 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 sterileunit. Several acceptable procedures exist. gauze over the point of entry of the(See Method 9.2.) Occasionally, donors needle into vein. (The donor may bemay be sensitive to the iodine. The SOP instructed to continue applicationmanual may provide an alternative of pressure for several minutes.)method, such as hexachlorophene soap Check arm and apply bandage onlyscrub followed by acetone- alcohol,10 to after all bleeding stops.use in this circumstance. After the skin 2. Have donor remain reclining on bedhas been prepared, it must not be touched or in donor chair for a few minutesagain 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 fpears in Method 9.3. The unit should be refreshment should be specified incollected from a single venipuncture. the SOP manual.During collection the blood should be 4. Give the donor instructions aboutmixed with the anticoagulant. The postphlebotomy care. The medicalamount of blood collected should be director may wish to include somemonitored 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 beforeappropriate amount has been collected, leaving.segments and specimen tubes must be b. Do not leave until released by afilled, and the needle and any blood-con- staff member.taminated waste disposed of safely. The c. Drink more fluids than usual inneedle must not be recapped; disposal the next 4 hours.must be in a puncture-proof container. d. Avoid consuming alcohol untilAfter 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 theother breaks in the skin.11 Gloves must head between the knees.also be worn by individuals who are in h. If any symptoms persist, eithertraining as phlebotomists and are re- telephone or return to the bloodquired when collecting blood from an bank or see a doctor. Copyright © 2002 by the AABB. All rights reserved.
  11. 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 canMost 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 toognize reactions and to provide initial rapid recovery, call the bloodtreatment. In many blood banks, donor bank physician or the physicianroom 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. 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. 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 andtions should be recorded on the donor transfusion of racially unmatched blood. Nrecord 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 virusfor 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: Universalshould be in the donor area. The distance precautions for prevention of transmission ofto the nearest emergency room or emer- human immunodeficiency virus, hepatitis Bgency care unit heavily influences deci- virus, and other bloodborne pathogens insions 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. 14. 86 AABB Technical ManualAppendix 4-1. Uniform Donor History Questionnaire*Donor History Questions American Association Food and Drug of Blood Banks (AABB)† Administration (FDA)A. General1. Have you ever given No specific requirement. A record shall be available fromblood under a different which unsuitable donors may bename? 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 beand 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 blooddonor or told not todonate blood?4. In the past 4 weeks, Prospective donors who are A donor taking Accutane® orhave you taken any pills, taking medications shall be Proscar® should be deferred frommedications, Accutane® evaluated by a qualified per- donating blood for at least 1or 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)15. Unexplained weight The prospective donor shall Donor must be determined to beloss: Have you lost appear to be in good health. in general good health. (21 CFRweight recently? (Standards B2.100) 640.3(b) April 1994) Copyright © 2002 by the AABB. All rights reserved.
  15. 15. Chapter 4: Donor Selection and Blood Collection 87CommentsSince the donor’s name may have changed, noting a previously used name can assist in theidentification of unsuitable donors.The donor should appear to be in good health. Pain, persistent cough, sore throat, cold or influenzasymptoms, headache, nausea, dizziness or extreme nervousness may be cause for deferral.Information regarding prior donations and deferrals should be considered when evaluating currenteligibility.In general, medications taken by a donor are not harmful to the recipient. Most donors takingmedications, even prescription medications, are acceptable blood donors. Deferral for most drugs is based on the nature of the disease process, not on properties of thedrug itself. This is true of most donors requiring antibiotics, anticonvulsants, anticoagulants,digitalis, insulin, systemic corticosteroids, vasodilators, and antiarrhythmic or anti-inflammatorydrugs. Isotretinoin (Accutane®), a drug used to treat acne, disqualifies a donor for 1 month, as itmay be a teratogen. For similar reasons, intake of finasteride (Proscar ®), a drug used to treatbenign 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 useand 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 todraw these donors may be: 1) a general approval included in the facility SOP manual or 2) anapproval given individually as each problem arises, provided that oral approval is documented onthe donor’s record. Drugs and medical conditions that are often permitted in blood donors, at the discretion of theindividual 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 undiagnosedserious illness (including HIV infection), and should be investigated further and evaluated by aphysician. Copyright © 2002 by the AABB. All rights reserved.
  16. 16. 88 AABB Technical ManualAppendix 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 ahave you given blood, tion should be not more source of Whole Blood more thanplasma, 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 amonths, have you been during the preceding 12 transfusion of Whole Blood or aunder a doctor’s care or months received blood or blood component within the pasthad a major illness or derivatives known to be 12 months should not donatesurgery? 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 CFRdisease, 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 haveor 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 shallbeen pregnant or are preclude routine donation.you pregnant now? (Standards B1.800) Copyright © 2002 by the AABB. All rights reserved.
  17. 17. Chapter 4: Donor Selection and Blood Collection 89CommentsDonors should not be bled of more than 525 mL of whole blood within an 8-week period. Inunusual circumstances more frequent donation is permissible with the written permission of theblood bank physician after examination. At least 48 hours must elapse before whole blooddonation for individuals who have undergone hemapheresis. At the request of the recipient’sphysician, and with the approval of a blood bank physician, consenting individuals may donatemore frequently if they are in a program to provide components from a single donor for a specificrecipient. In such cases, except for donation interval, the donors must meet all the usual criteriafor allogeneic donors.Donors who have undergone operations should be deferred for at least 12 months if they receivedblood 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 thatmight indicate the donor is not in good health should be referred to a blood bank physician forfurther evaluation.A history of heart disease that may result in acute heart failure associated with the blood donationis cause for deferral, unless evaluated and approved by the blood bank physician. Active pulmonary tuberculosis, or any active pulmonary disease, is cause for deferral. Previoustuberculosis, successfully treated and no longer active, need not disqualify a donor. Donors witha history of a reactive tuberculin skin test may be accepted provided they are not under treatmentor receiving prophylactic therapy.Prospective donors who have had cancer, other than localized skin cancer or carcinoma-in-situof 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 beacceptable donors. Donors who have or have had leukemia or lymphoma must be permanentlydeferred. If the donor has another blood disease, it should be evaluated by the blood bankphysician. An abnormal bleeding tendency may be cause for deferral subject to evaluation by the bloodbank physician. Individuals with such a history may experience excessive bleeding at the site ofvenipuncture and require special care following donation.Defer donors during pregnancy and for 6 weeks following conclusion of pregnancy. Exceptionsmay be made by a blood bank physician if the woman’s blood is intended for transfusion to herinfant. Pregnancy is not an absolute contraindication for autologous collection (see Chapter 5). Copyright © 2002 by the AABB. All rights reserved.
  18. 18. 90 AABB Technical ManualAppendix 4-1. (continued)Donor History Questions American Association Food and Drug of Blood Banks (AABB)† Administration (FDA)C. Questions to protect the recipient1. In the past 3 days, Ingestion of aspirin or other No specific requirement for wholehave you taken aspirin, medications that inhibit blood donation. Donors who haveor 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)32. Have you ever had Prospective donors with dis- No individual with a history ofyellow jaundice, liver eases of the liver shall be hepatitis shall be source of wholedisease, 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. 19. Chapter 4: Donor Selection and Blood Collection 91CommentsCompounds containing aspirin or other medications that inhibit platelet function and have aprolonged half-life depress platelet function for 1-5 days. Platelets from a donor who has takenaspirin 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 establishedand 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. 20. 92 AABB Technical ManualAppendix 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 fluidstattoo, ear or skin blood or blood components through percutaneous inoculationpiercing, acupuncture, for transfusion who, within (such as injury or accidentalaccidental needlestick, the preceding 12 months, needlestick) or through contactor come in contact with have a history of: 1) a tat- with an open wound, nonintactsomeone 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 whomonths, have you had tact with a person who has has viral hepatitis shall result inclose contact with a viral hepatitis is cause for 12-month deferral. (FDA Memoperson with yellow 12-month deferral. (Stand- 4/23/92)5jaundice or hepatitis, or ards B2.724)have you been givenHepatitis B ImmuneGlobulin (HBIG)?5. In the past 12 History of blood transfu- Persons who have received amonths, have you sion is cause for 12-month transfusion of Whole Blood or areceived blood or had an deferral. (Standards B2.420) blood component within the pastorgan or tissue 12 months should not donatetransplant? blood or blood components. (FDA Memo 4/23/92)2 Copyright © 2002 by the AABB. All rights reserved.
  21. 21. Chapter 4: Donor Selection and Blood Collection 93CommentsDonors should be questioned about ear piercing, skin piercing, electrolysis, and acupuncture tomake 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 needlestickinjury 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 for12-month deferral from the time the exposure occurred.The type of contact that hospital personnel and physicians encounter may not be cause per se fordeferral. Donors who had unprotected or accidental exposure to blood and body fluids in ahealth-care setting or other job should be deferred. Percutaneous exposures (ie, needlesticks ormucous 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 beinfectious for HIV or HBV unless visibly contaminated with blood. Defer for 12 months prospectivedonors 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 possiblesources of the Creutzfeldt-Jakob agent must be indefinitely deferred from blood donation. Personswho have received a transfusion of Whole Blood or a blood component, or other tissue allograftswithin the past 12 months, should not donate blood or blood components. Copyright © 2002 by the AABB. All rights reserved.
  22. 22. 94 AABB Technical ManualAppendix 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 diseasehave 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 ofdisease called Creutzfeldt-Jakob disease be per-Creutzfeldt-Jakob manently deferred from donationdisease (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. 23. Chapter 4: Donor Selection and Blood Collection 95CommentsTravelers 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, providedthey 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 interviewingpersonnel to determine which areas are considered endemic. It is helpful to have a recent world map available to personnel interviewing donors to locateareas where travelers or immigrants have been. Immigrants, refugees, citizens, or residents coming from an area in which malaria is endemicmust be deferred for 3 years after departure from the malarial area, if they have been asymptomaticin the interim. Donations from which only the plasma will be used are exempt from theserestrictions.Donors with a history of disease caused by either Babesia species or Trypanosoma cruzi must beindefinitely deferred. Persons who originate from Latin America, especially rural areas, may haveT. cruzi infection without evidence of acute symptoms in the past. More detailed follow-upquestions 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 individualsduring rigorous physical training. Several cases of Creutzfeldt-Jakob disease (CJD) have beenreported in persons given pit-hGH. Since the agent causing this disease might be transmissibleby transfusion, donors who have received pit-hGH must be indefinitely deferred. Deferral is notnecessary 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 betransmitted by brain tissue or membranes.Familial Creutzfeldt-Jakob disease (CJD) has been described. Copyright © 2002 by the AABB. All rights reserved.
  24. 24. 96 AABB Technical ManualAppendix 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 beenmonths, have you had a orrhea, or treatment for treated for, syphilis or gonorrheapositive test for syphilis? either, shall be cause for de- during the preceding 12 months11. B. In the past 12 ferral for 12 months after should not donate blood or bloodmonths, 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 12or gonorrhea? months. (FDA Memo 12/12/91)712. 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 drugsmoney or drugs to anyone high-risk activity, and such since 1977 and persons who haveto have sex with you? At at-risk persons should re- engaged in sex with such peopleany time since 1977, have frain from donating blood. during the preceding 12 monthsyou taken money or drugs (Standards B2.730 and should not donate blood or bloodfor sex? In the past 12 B3.100) components. (FDA Memomonths, have you had 4/23/92)2sex, even once, withanyone who has had sexfor drugs or money?13. A. Have you ever A. Evidence of narcotic ha- A. Donor must be free from skinused 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 or13. B. In the past 12 B. Refer to question #12. present intravenous drug usersmonths, have you had should not donate blood or bloodsex, even once, with components. (FDA Memo 4/23/92)2anyone who has used a B. Persons who have had sex withneedle 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. 25. Chapter 4: Donor Selection and Blood Collection 97Comments 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 preceding12 months must be deferred.Men and women who have engaged in sex for money or drugs since 1977 and persons who haveengaged in sex with such people during the preceding 12 months should not donate blood orblood components.Use of intravenous drugs under nonsterile conditions puts a person at high risk for infection withHIV, hepatitis, HTLV-I or II, as well as other transmissible disease agents. Because of thepropensity of repeat behavior associated with the use of addictive drugs, users of intravenousdrugs are deferred indefinitely. Their sexual partners are deferred for 12 months after the lastsexual 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 indefinitedeferral. Copyright © 2002 by the AABB. All rights reserved.
  26. 26. 98 AABB Technical ManualAppendix 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 sinceanother male, even once 1977 should not donate blood orsince 1977? blood components permanently.Female Donors: In the Females who have had sex withpast 12 months, have men who have had sex with an-you had sex with a male other man even one time sincewho has had sex, even 1977 should not donate blood oronce since 1977, with blood components for 12 months.another male? (FDA Memo 4/23/92)215. A. Have you ever No specific requirement. A. Persons with hemophilia or re-taken clotting factor lated clotting disorders who haveconcentrates for a received clotting factor concen-bleeding problem, such trates should not donate blood oras hemophilia? blood components. (FDA Memo 4/23/92)215. B. In the past 12 B. Persons who have had sex withmonths, have you had any person with hemophilia or re-sex, even once, with lated clotting disorders who haveanyone who has received clotting factor concen-received a clotting factor trates should not donate blood orconcentrate? blood components for 12 months. (FDA Memo 4/23/92)216. A. Do you have AIDS Refer to question #12. A. Persons with clinical or labora-or have you had a tory evidence of HIV infectionpositive test for the must not donate blood or bloodAIDS virus? components. (FDA Memo 4/23/92)216. B. In the past 12 B. Persons who have had sex withmonths, have you had persons with clinical or laboratorysex, even once, with evidence of HIV infection shouldanyone who has? not donate blood or blood compo- nents for 12 months. (FDA Memo 4/23/92)217. Are you giving blood No specific requirement. No specific requirement.so that you will betested for AIDS?18. Do you understand No specific requirement. Donors should be informed thatthat if you have the AIDS there is an interval during early in-virus, you can give it to fection when the HIV tests may besomeone else even negative although the infectionthough you may feel may still be transmitted. (FDAwell and have a negative Memo 4/23/92)2AIDS test? Copyright © 2002 by the AABB. All rights reserved.
  27. 27. Chapter 4: Donor Selection and Blood Collection 99CommentsMen who have had sex with another man even one time since 1977 should not donate blood orblood components. Females who have had sex with men who have had sex with another man evenone 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 totransmissible disease agents and must be deferred indefinitely. Their sexual partners must bedeferred 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 bloodcomponents. Persons who have had sex with persons with clinical or laboratory evidence of HIVinfection should not donate blood or blood components for 12 months.Due to the possibility of donation during the seronegative “window” period of infection, individualsmust be strongly discouraged from donating blood just to get tested for HIV. Alternative site testingshould 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 testsfor HIV, done on all donations, may not detect infection. Information should be provided aboutdonor deferral registries. Persons who are not suitable as donors but desire to learn their teststatus should be given instructions about alternate mechanisms to obtain testing. Copyright © 2002 by the AABB. All rights reserved.
  28. 28. 100 AABB Technical ManualAppendix 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 inunderstood all the donor language that ensures that the do-information presented to nor understands the definition ofyou, and have all your high-risk behavior and the impor-questions been tance of self-exclusion. Donorsanswered? 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)2References 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 theFDA. 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 notbeen approved by the FDA at time of publication.† Standards referred to are from the 17th edition of Standards for Blood Banks and TransfusionServices, effective June 1, 1996. Copyright © 2002 by the AABB. All rights reserved.
  29. 29. Chapter 4: Donor Selection and Blood Collection 101CommentsDonors must be given educational material informing them of high-risk activities for AIDS and thenecessity of refraining from donating blood if at risk. All donors must be asked if they have readand understood the educational material informing potential donors that persons at increased riskof AIDS should refrain from donating blood. Copyright © 2002 by the AABB. All rights reserved.
  30. 30. 102 AABB Technical ManualAppendix 4-2. Some Drugs Commonly Accepted in Blood DonorsIn many blood centers, blood donation may be allowed by individuals who have taken the followingdrugs: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 medicaldirector. Copyright © 2002 by the AABB. All rights reserved.