Blood Blood Component Donor Selection and Collection

1. Blood & Blood Component Donor Selection and Collection Bill Zaloga, D.O. MCG Transfusion Medicine May 2005

2. General Information Eligibility is determined through a standardized screening process required by the US Food an Drug Administration. During this process you are asked questions regarding your health history. Donor screening protects the blood supply and donor: Medical history is obtained on the day of donation and a limited physical exam is on day of donation. A qualified physician or designee determines donor suitability. Donor selection and collection criteria are established by FDA regulation, AABB voluntary standards, guidelines and local standards of practice; when a donor condition is not addressed by these a physician determines suitability. The Blood Bank Medical Director may waive (and document) standard donor criteria. Allogeneic Whole Blood Manual Donation is most commonly performed with subsequent component preparation (Described first with distinguishing features of other types of donation following). Whole blood donation takes about an hour. The blood collection itself is ten minutes. The process includes registration, a brief medical screening, blood collection, and refreshments. Expect up to two hours for apheresis (platelet) collections. The donor should eat a meal and drink plenty of fluids before donating. Drinks high in caffeine should be avoided because they can dehydrate the body. Normally plasma volume, platelets lost, iron levels and red cells lost will be replaced in 24hours, 2 days, 42 days and 56 days respectively. General qualification for blood donation: general good health, weigh at least 110 pounds, no history of hepatitis, no risk of HIV. Age is defined by state law or > 17 year. No standard of upper age limit is required but must be determined safe. Minors may donate with proper consent of parents or guardian. Donors shall be notified of any medically significant abnormalities. The donor is deferred until all requirements for safe donation are met. Deferred donors should receive a full explanation and be informed when they can return to donate. If an autologous donor is deferred, the donor and referring physician shall be notified. Blood collection records are retained indefinitely. The donation record identifies the examiner(s) and records observations and tests. Blood donation adverse events are captured, assessed, investigated, and monitored. The FDA shall be notified of donor or recipient fatalities.

3. Information provided for donors prior to donation The donor qualification process is private and information obtained is confidential, released only with authorization of Blood Bank Medical Director. Donation requires written signed and dated informed consent that allows collection and use of blood before donation. Risks of procedure include dizziness, faintness, nausea, vomiting, pain, ecchymosis, blood loss, hematoma, phlebitis, venous clot formation, seizure, air embolus, infection, bacteremia and sepsis, and significant adverse events discussed later. Definitions of sexual contact, signs and symptoms of AIDS and high risk activities defined by FDA, foreign travel donation risks, tests done on their blood (should know that testing and notification will occur if after collection the donor indicates the unit should not be transfused), ineligible donor registries, window periods of infections, investigational testing (NAT), donor notification of abnormal tests and deferral status, and information that in some circumstances infectious disease tests are not done. FDA required infectious disease tests: HIV 1&2, HBV, HCV, HTLV I&II, and syphilis. MCG also performs NAT testing for HIV, HCV and WNV (AABB standards require methods to limit and detect bacteria contamination of platelets). Donors must document information to be accurate, understanding of donation process and blood testing, and that donation is a voluntary informed decision. MCG maintains a record of deferrals in the donor room.

4. MCG Donor Education Material MCG HEALTH, INC. DEPARTMENT OF PATHOLOGY CLINICAL LABORATORIES BLOOD BANK, APHERESIS AND DONOR ROOM, 1120 15TH STREET, AUGUSTA, GEORGIA 30912 (ORIGINAL DATE 06/16/03) (AUTHOR MEW/SCW) BLOOD DONOR EDUCATIONAL MATERIAL Thank you for coming in today! This information sheet explains how YOU can help us make the donation process safe for yourself and patients who might receive your blood. PLEASE READ THIS INFORMATION BEFORE YOU DONATE. If you have any questions, please ask our staff. ACCURACY and HONESTY ARE ESSENTIAL! All information you provide is confidential. DONOR ELIGIBILITY - SPECIFIC INFORMATION Why we ask questions about sexual contact: Sexual contact may cause contagious diseases like HIV, hepatitis and certain other viruses such as syphilis or gonorrhea to get into the bloodstream and can be spread through transfusions to someone else. Definition of "sexual contact": The words "have sexual contact" and "sex" are used in some of the questions we will ask you, and apply to any of the activities below, whether or not a condom or other protection was used: Vaginal sex (contact between penis and vagina), Oral sex ( mouth or tongue on someone's vagina, penis or anus), Anal sex (contact between penis and anus) HIV/AIDS Risk Behaviors and Symptoms: AIDS is caused by HIV. HIV is spread mainly though sexual contact with an infected person OR by sharing needles or syringes used for injecting drugs.

5. MCG Donor Education Material DO NOT DONATE IF YOU: Have AIDS/HIV or have ever had a positive AIDS/HIV test; Have hepatitis or have ever tested positive for hepatitis; Have ever used needles to take drugs, steroids, or anything not prescribed by a doctor even once;Have ever taken money, drugs or other payment for sex since 1977;Are a male who has had sexual contact with another male, even once, since 1977; Are a hemophilia who has received clotting factor concentrates; Have lived in, been born in or traveled to Haiti, Central Africa, islands off West Africa, Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger or Nigeria; Have had sexual contact in the past 12 months with anyone described above; Have had syphilis, gonorrhea or venereal disease in the past 12 months; In the past 12 months have been in juvenile detention, lockup, jail or prison for more than 72 hours; or Have any of the following conditions that can be signs or symptoms of HIV/AIDS: Unexplained weight loss or night sweats; Blue or purple spots in your mouth or on your skin; White spots or unusual sores in your mouth; Swollen lymph nodes more than one month; Diarrhea that won't go away; Fever above 99� for more than 10 days; Cough that won't go away or shortness of breath not related to smoking or respiratory ailment. Remember you can give HIV to someone else through blood transfusions even if you feel well and have a negative HIV test. This is because tests cannot detect infections for a period of time after a person is exposed to HIV. If you think you may be at risk for HIV/AIDS or want a HIV/AIDS test, please ask about other testing facilities.PLEASE DO NOT DONATE BLOOD TO BE TESTED FOR A HIV/AIDS, HEPATITIS OR ANY OTHER INFECTIOUS DISEASE. Travel to or birth in other countries: Blood test may not be available for some contagious diseases that are found only in certain countries. Let us know of any travel outside the United States or contact with anyone who has been outside the United States. This may make you ineligible to donate.

6. Donor registration Must allow full identification and link to donor to current and previous records. Current information with each donation. Must be possible to notify donor of any abnormalities in physical exam, medical history or post-donation laboratory tests.

7. Donor registration should include Donation date and time. Last and first name (middle initial if available). Addresses. Telephone numbers. Gender. Age (or DOB). Previous deferral record must be consulted. Confirm identification and source of identification.

8. Medical History The most recent FDA-approved uniform donor history questionnaire is recommended by the AABB and available on their web site, www.aabb.org. A donor may be deferred based on history (drugs, medications, immunizations, medical conditions, travel, other) or physical exam. Confidential self-deferral opportunity should be offered before phlebotomy starts.

9. From AABB, www.aabb.org

10. From AABB, www.aabb.org

11. Deferrals Resources: The US Department of Defense maintains a list of blood donation deferrals for drugs, medications, and immunizations. The US Centers for Disease Control and Prevention maintains a list of blood donation deferrals for common health problems, international travel, and malaria/vCJD risk countries. The AABB has a medication deferral list at www.aabb.org. MCG has a Donor Deferral for Community Donor Manual in the Donor Room. Permanent deferral records are kept indefinitely and temporary deferrals are kept for the deferral period. Blood specimens will be collected for infectious disease testing and a donor may be deferred if results are equivocal until results are clarified. The donor and their physician will be notified of positive results. Counsel or referral must be provided for medically significant abnormalities. Deferrals may be temporary, indefinite or permanent. If donor is not feeling well they are deferred until they feel better and it is determined the underlying illness will not cause deferral. Mild allergy symptoms may be acceptable. Donor must be free of infectious disease and colds, acute respiratory disease, or history of diseases of the heart or lungs. Blood donor procedures which do not have the red cells returned should not collect more than 525 mL of blood in any 8 week period, and 16 weeks for an apheresis double red cell product.

12. Some more deferrals 24 hour deferral: Recipients of toxoids or synthetic or killed viral, bacterial, or rickettsial vaccines if donor is symptom free and afebrile (anthrax, cholera, diptheria, prophylactic hepatitis A (not for exposure), hepatitis B, influenza, lyme disease, paratyphoid, injected pertussis, plaque, pneumococcal polysaccharide, salk injection polio, rock mountain spotted fever, tetanus, typhoid injection). Human diploid cell rabies vaccine, unless given for animal bite then defer one year after treatment. Dental work is a 24 to 72 hour deferral depending on procedure and longer if complications. Donors with irreversible platelet inhibitors (aspirin or piroxicam) deferred for 36 hours and cannot be used as sole source of platelets (precludes apheresis platelet donation). When platelets are not a desired component aspirin containing medications and paroxicam are acceptable. MCG SOP allows up to 3 attempts of donor vascular access with donor permission. If 3 attempts fail, then defer donor > 1 day. 2 week deferral: Recipients of live attenuated viral and bacterial vaccines (measles/rubeola, mumps, sabin oral polio, oral typhoid, oral pertussis, yellow fever; but german measles/rubella, and chicken pox/varicella zoster is a 4 week deferral). 4 week deferral: Illegal medicine use (use of a needle to administer drugs not prescribed by a doctor is a permanent deferral).

13. Some more deferrals 1 month deferral: Finasteride (Proscar, Propecia), Isotretinoin (Accutaine), Ticlopidine. 3 month deferral: Bacteremia (A donor with infection or taking an antibiotic shouldn�t donate if the infection can be transmissible by blood). 6 week deferral: Avodart, pregnancy. 6 month deferral: A person who had a seizure. 12 month deferral: Recipient of allogeneic blood or blood components plasma-derived clotting factors. Cocaine use. Travel to Iraq. Mucus membrane exposure or nonsterile skin penetration, including tattoos, contaminated with allogeneic blood or body fluid. Sex with a confirmed positive HBsAg individual. Sex or household contact with a viral hepatitis, (HBV or HAV or unknown, or person symptomatic in the last 12 months with HCV) or jaundiced individual (healthcare workers taking standard precautions are acceptable). Sex or close contact with anyone who has ever used needles to take drugs not prescribed by a doctor. Sex with a hemophiliac or clotting factor user. Women who had sex with a man who had sex with another man since 1977. Correctional institution incarceration for more than 72 hours. A person treated for syphilis or gonorrhea or any STD or a reactive screen test for syphilis without a negative confirmatory test. Following initial exposure or chronic disease like herpes if currently inactive. 3 years deferral: Acitretin (Soriatane). Malaria diagnosis or living/traveling to a malaria endemic area with malaria suggestive symptoms (chronic recurring or relapsing fevers after physician evaluation) after they�re treated and asymptomatic (travel to a malaria endemic area in itself is a 12 month deferral after they leave). A person after leaving a malaria endemic (per CDC) area where they lived 5 or more consecutive years. Antimalaria prophylaxis doesn�t change malaria deferral periods. 5 year deferral: diagnosis or treatment for alcoholism.

14. Some more deferrals Permanent deferral: Etretinate (Tegison). Severe chronic medical illness (ex. Cirrhosis, severe renal disease, congenital blood disease, adrenal disease, autoimmune disease, severe heart or lung disease, or disease of unknown cause). Heart disease that may result in heart failure. Blood disease or clotting disease. History of Babesiosis or Chagas� disease. Any organ transplant recipient (in MCG SOP), (AABB guideline: transplant of organ or human tissue or marrow is a 1 year deferral). Insulin dependent diabetes (diet or oral medication controlled diabetes acceptable). Indefinite deferral: Evidence of obvious stigmata of parenteral drug use. Confirmed positive HBsAg, anti-HBc reactivity on more than one occasion. Clinical or lab evidence of HCV or HTLV. Clinical or lab evidence or exclusion by FDA criteria for HIV transmission by blood or components. Apparent transmission of hepatitis or HIV or HTLV by the donor�s unit that was the sole unit transfused. Blood transfusion or medical treatment receipt in Africa since 1977. Birth or residence since 1977 in Cameroon/ Central African Republic/ Chad/ Congo/ Equatorial Guinea/ Gabon/ Niger/ Nigeria (due to the rare strain HIV group O which is not consistently detected by all current test methods) or had sex with one of these persons. Permanent deferral: Hepatitis B or C clinical or laboratory evidence, or history of viral hepatitis at age 11 or older. Men who had sex with another man since 1977. Prostitution or sex with a prostitute since 1977. HIV positive persons or sex with an HIV positive person. Persons with clinical or lab evidence of HIV or HTLV I-II or sex with one of these persons.

15. Newer deferrals (CJD, vCJD FDA guidance) Indefinite deferral: Diagnosis of CJD or vCJD. Donors at risk for vCJD including donors who received tranfusion of blood or components or bovine insulin from the UK since 1980. 3 or more cumulative months in the UK from 1980 to 1996. 5 or more cumulative years in France since 1980. Northern Europe US military base residents of 6 months or more from 1980 to 1990; and other European military base resident of 6 months or more from 1980 to 1996. More than 5 years cumulative residence in Europe since 1980. Family history of CJD, if genetic relative. Recipient of dura mater or human pituiatry growth hormone.

16. Newer deferrals (WNV FDA guidance) Standard procedures that are already in place should result in deferral of potentially infected individuals who have symptoms consistent with WNV illness at the time of donation. Such individuals are likely to manifest fever, headache, eye pain, body aches, a generalized skin rash, or swollen lymph nodes (AABB guidelines recommend donor deferral if symptoms occurred within the last week and for 28 days after interview date). The following recommendations apply to cases of known or suspected WNV illness, or active infection. Although there are limited data on the natural course of WNV infection, the deferral periods we are recommending are based on the longest known viremic period, plus an additional margin of safety: Diagnosed or Suspected Acute West Nile Virus Illness or Infection: defer a potential donor with a medical diagnosis or suspicion of WNV infection (based on symptoms and/or laboratory results) for 120 days following diagnosis or onset of illness, whichever is later; In the absence of a WNV compatible illness in the previous two weeks, an IgM positive WNV antibody test result alone should not be grounds for deferral provided that the donor was tested and found to be negative by minipool (MP) or Individual Donation Testing (IDT) WNV NAT at the time of collection. Presumptive Viremic Donors: We recommend that you defer a donor who has tested reactive for WNV infection using the investigational WNV NAT donor screening tests. At your discretion, you may choose to reenter such donors after 120 days from their reactive donation, provided that they are retested and found negative by IDT NAT for WNV on a follow-up sample obtained during or after the 120 day deferral period. If the follow-up sample is reactive for WNV, we recommend that the donor be deferred for an additional 120 days from the date the sample was collected, and that the donor be retested and found negative by IDT NAT for WNV before reentry after the second deferral period. Suspected West Virus Illness in a Donor: We recommend that donors who report during WNV season (at least between May 1 and November 30) an otherwise unexplained post-donation febrile illness with headache or other symptoms suggestive of WNV infection (i.e., flu-like symptoms that include fever with headache, eye pain, body aches, generalized weakness, new skin rash or swollen lymph nodes or other evidence of WNV infection), be deferred for 120 days following the onset of illness. Donors Who May Have Transmitted West Nile Virus Infection: We recommend that blood donors whose blood or blood components were potentially associated with a transfusion-related WNV transmission be deferred with a provision for re-entry 120 days following the date of donation, based upon negative test results with IDT NAT.

17. Newer deferrals (SARS FDA guidance) We recommend that donors reporting a history of SARS or suspected SARS be asked about duration of symptoms and any treatment given. We recommend that you defer these donors for a period of at least 28 days after complete symptom resolution AND the cessation of any treatment. For asymptomatic donors with a history of contact with persons with SARS or suspected SARS, we recommend that you defer these donors for a period of at least 14 days after last exposure. For travel/residence exposure, the donor should be deferred for at least 14 days after arrival in the United States. Refer to the CDC website (www.cdc.gov/ncidod/sars/casedefinition.htm) or call CDC (888-246-2675) for updated information. Currently (May 3, 2005), there is no known SARS transmissions anywhere in the world. The most recent human cases of SARS-CoV infection were reported in China in April 2004. SARS signs and symptoms (from CDC): The illness generally begins with a prodrome of fever (>100.4�F [>38.0�C]). Fever often is high, sometimes is associated with chills and rigors, and may be accompanied by other symptoms, including headache, malaise, and myalgia. The incubation period for SARS is typically 2�7 days; however, some reports have suggested an incubation period as long as 10 days. At the onset of illness, patients may have mild respiratory symptoms. Typically, rash and neurologic or gastrointestinal findings are absent; however, some patients have reported diarrhea during the febrile prodrome.After 3�7 days, a lower respiratory phase begins with the onset of a dry, nonproductive cough or dyspnea, which may be accompanied by or progress to hypoxemia. In 10%�20% of cases, the respiratory illness is severe enough to require mechanical ventilation. The case-fatality rate has been estimated to be 13.2% for patients <60 years of age and 43.3% for patients 60 years of age or more.Chest radiographs may be normal during the febrile prodrome and throughout the course of illness. However, in a substantial proportion of patients, the respiratory phase is characterized by early focal interstitial infiltrates progressing to more generalized, patchy, interstitial infiltrates. Some chest radiographs from patients in the late stages of SARS also have shown areas of consolidation.

18. Newer deferrals (SARS FDA guidance) Donor Interview Questions At donor interview, in the event that CDC has identified SARS-affected areas as existing within the previous 90 days, we recommend that you ask (orally or in writing) potential donors about: History of SARS, suspected SARS, or treatment for SARS within the previous 28 days; Close contact within the previous 14 days with persons with SARS or suspected SARS; Ninety days after CDC has lifted all travel alerts for SARS-affected areas, we recommend that you discontinue asking donors these questions. At donor interview, in the event that CDC has identified SARS-affected areas as existing within the previous 14 days, we recommend that you ask (orally or in writing) potential donors about: Travel to or residence in SARS-affected areas within the previous 14 days; you should read to or show donors a list of SARS-affected areas as updated by CDC; Fourteen days after CDC has lifted the travel alert for a geographic area, we recommend that you discontinue asking donors questions concerning travel or residence in that area related to SARS. AABB guidelines: close contact (standing within 3 feet of a person with SARS, touching a person with SARS, living with a person with SARS, care for a person with SARS, kissing-embracing-or sharing eating utensils or a person with SARS; but not walking past a person or briefly sitting across a room from a person with SARS) of a person with or who may have SARS entails activities that may produce contact with respiratory secretions, or body fluids of a person with SARS during the clinical illness or 10 days after resolution of symptoms.

19. Newer deferrals (Smallpox FDA guidance) Rationale for Deferral of Recipients of Smallpox Vaccine: The immune response to vaccinia includes neutralizing antibodies and a cellular immune response. Neutralizing antibodies are detected by 10 days after primary vaccination, reach peak levels around 2 weeks, and may persist for months to years. Cell mediated immunity to vaccinia can be detected after primary vaccination, and may persist for up to 50 years. There are no known cases of vaccinia virus persistence in the absence of a clinically recognizable infection. Vaccinia virus is readily recovered from the vaccination site until the vaccination scab spontaneously separates from the skin. The scabs themselves contain infectious virus. Thus, although viremia is unlikely once an immune response is initiated, recipients of the vaccine could still inadvertently infect close contacts who touch the vaccination site or dressing. Vaccinia virus can be recovered from the skin at the vaccination site for a mean duration of 7.8 days, with a range of 0 to 18 days. Based on these considerations, and until more information is available, we recommend that you defer donors who received smallpox vaccine until after the vaccine scab has spontaneously separated. We will continue to evaluate our recommendations in light of evolving scientific knowledge about vaccinia virus.

20. Newer deferrals (Smallpox FDA guidance) Rationale for Deferral of Donors with Complications of Smallpox Vaccination: Viremia has been more readily detected in people with moderate or severe complications of vaccinia virus infection. These complications include generalized vaccinia, eczema vaccinatum, and progressive vaccinia. The occurrence of viremia in cases of encephalitis or vaccinial keratitis has not been demonstrated. Ecczema vaccinatum - a localized or systemic dissemination of vaccinia virus in someone with eczema (atopic dermatitis) or a history thereof, or with other chronic or exfoliative skin conditions. Generalized vaccinia - is characterized by a vesicular rash of varying extent that can occur among persons without underlying illness. The rash is generally self-limited and requires minor or no therapy except in rare cases, when the vaccine recipient is systemically ill. Progressive vaccinia (vaccinia necrosum) is a severe, potentially fatal illness characterized by progressive necrosis in the area of vaccination, often with metastatic vaccinia lesions. It has occurred almost exclusively among persons with cellular immunodeficiency. Postvaccinial encephalitis - a rare but serious complication of vaccinia virus infection involving the meninges of the brain and spinal cord. Vaccinial keratitis - an infection of the cornea, which can cause corneal scarring and visual impairment. This condition is usually caused by accidental self-inoculation of the eye from the vaccine site or from self-inoculation after contact with another vaccine recipient, and is not believed to be due to the hematogenous spread or associated with a secondary viremia.

21. Newer deferrals (Smallpox FDA guidance) Rationale for Deferral of Donors Who Have Contracted Symptomatic Vaccinia Virus Infection through Close Contact with a Vaccine Recipient: Persons infected by close contact with a vaccine recipient usually develop vaccinia lesions on their own skin, since the virus is transmitted to them by skin contact with the vaccination site or with other parts of the body or clothing that has been recently contaminated with vaccinia virus. Defer donors who have had contact with someone else who has received the vaccine only in cases where the donors have recognizable signs or symptoms attributable to the virus. These donors present the same risks to blood recipients and collection center staff as someone who has been recently vaccinated. However, donors who have been exposed to a vaccinee, but who fail to develop signs or symptoms of infection by vaccinia, are unlikely to be infected. If infected donors have a single, localized lesion, we recommend that they be deferred until the scab has spontaneously separated. In cases where the scab was otherwise removed, we recommend deferral periods based on the date of vaccination of the vaccine recipient. As with smallpox vaccine recipients, if the contacts have complications of their vaccinia virus infection, we recommend that they be deferred until 14 days after all complications have completely resolved. Rationale Concerning Asymptomatic Contacts of Vaccine Recipients: Asymptomatic contacts of vaccinees are unlikely to be infected and we do not recommend that they be deferred.

22. Newer deferrals (Smallpox FDA guidance) For donors who state that they have been vaccinated within the past two months, collection center staff should visually inspect the site of the vaccination (usually on the upper arm) to determine whether the scab has separated from the skin, and if there has been recent vaccination we recommend that they inquire whether the scab separated spontaneously. We recommend that all donors be asked the following donor deferral questions: �In the past eight weeks, have you received smallpox vaccination or have you had close contact with the vaccination site of anyone else?� (Examples of close contact include physical intimacy, touching the vaccination site, touching the bandages or covering of the vaccination site, or handling bedding or clothing that had been in contact with an unbandaged vaccination site). �Has the vaccination scab fallen off your skin by itself? Did you have any illness or complications due to the vaccination?� (If the donor had smallpox vaccination ). �Have you had any new skin rash or skin sore since the time of contact?� (If close contacts had smallpox vaccination). Deferral of Recipients of Smallpox Vaccine: For donors who recently have received smallpox vaccine, as identified by donor questioning. Donors without vaccine complications should be deferred until after the vaccination scab has separated spontaneously, or for 21 days post-vaccination, whichever is the later date. Donor room staff should visually verify absence of the vaccination scab and ask if it separated spontaneously. In cases where a scab was removed prior to separating spontaneously, we recommend that you defer the donor for two months after vaccination. We recommend that you defer donors who have experienced complications of vaccination until 14 days after all vaccine complications have completely resolved.

23. Newer deferrals (Smallpox FDA guidance) Deferral of Symptomatic Contacts of Recipients of Smallpox Vaccine: The following recommendations apply to donors who acquired a clinically recognizable vaccinia virus infection by close contact with someone who received the smallpox vaccine. Donors with localized skin lesions and without any other symptoms or complications: Donor room staff should visually verify the absence of the localized skin lesion (scab) and ask if it separated spontaneously. If the localized skin lesion (scab) separated spontaneously, and is no longer present, the donor need not be deferred based on the prior exposure to a smallpox vaccine recipient. In cases where a scab was otherwise removed, we recommend that the donor be deferred for a period of three months from the date of vaccination of the vaccine recipient with whom the contact occurred. If the date is not known, but could have been within the last three months, we recommend that you defer the donor for two months from the present time. Donors with Complications of Smallpox Vaccination: To assure a margin of safety, we recommend that you defer donors with complications of vaccinia, acquired by vaccination for 14 days after complete resolution of the complication. Donors who have experienced complications of vaccinia infection acquired through close contact with a vaccine recipient: We recommend that you defer donors who have experienced complications of vaccinia infection acquired through close contact with a vaccine recipient until 14 days after all vaccine complications have completely resolved.

24. Physical Exam Predonation medical exam: weight, temperature, pulse, hemoglobin, blood pressure, limited physical exam. If general appearance (example: ill or intoxicated) is inappropriate then defer. Donor temperature must not exceed 37.5 C (99.5 F) orally or equivalent. If < 96 F, test with alternate method. Pulse should be 50-100 beats per minute, without pathologic irregularity. <50 bpm acceptable for athletes. Blood pressure should be no higher than 180 systolic and 100 diastolic. Acceptable Hemoglobin (Hgb) and Hematocrit (Hct) at donation: autologous donor Hgb 11-18 g/dL and Hct 33%-52%. All other type donors Hgb 12.5-18 g/dL and Hct 38%-52%. If over limits, test a venous sample. Venipuncture site skin (usually antecubital area) must be without lesions, remaining skin should be without significant lesions. Donor may be deferred for inadequate veins. Collection facility medical director are responsible for patient during collection, during the transfusion the patient�s physician and medical director of transfusion service are responsible for the patient.

25. Blood collection Aseptic methods with sterile closed system. Identify the donor record with the donor and all items associated with donor include: collecting and processing institution, phlebotomist, date, time, expiration, component type, volume, storage temperature, special requirements. FDA-approved container must be sterile and pyrogen-free with anticoagulant type and volume noted. Labels with an identifying system are established that identifies each donor, donor record, specimens, collection container and all components. Attached at the time of collection and to all future processed materials. Recheck all numbers and labels. Record type of donation and any processing of unit. For a standard collection bag=450 +/- 45 mL (an underbled (100-300 mL), or overbled (>495 mL) unit is disposed). A low volume unit (300-404 mL) may be transfused if labeled and only whole blood or red cells are transfused. MCG processes the following components: Whole blood (stored at 1-6 Celsius within 30 minutes of collection). Whole blood or plasma to produce platelets, or plateletpheresis is stored at 20-24 Celsius immediately with gentle agitation. If whole blood collection time < 15 minutes with minimal trauma to activate coagulation, FFP may be prepared, and if > 15 minutes, single donor plasma is prepared and discarded. Whole blood is stored, and centrifuged at 1-6 Celsius into fresh frozen plasma which is stored at minus 18 Celsius or colder within 8 hours of collection of whole blood. Apheresis is also used to collect red cells, plasma or platelets. Plasma appearance is noted if unusual (usual: clear golden yellow, sometimes green tint with birth control pills, or white if lipemic). Extremely lipemic or icteric units should not be used, labeled a single donor plasma and discarded. At MCG, sterility must be maintained in component preparation or else discard product.

26. Blood Collection Whole blood donation volume must be <10.5 ml blood/kg of body weight per donation, including test samples. If > 110 pounds, remove no more than 525 mL whole blood. If 100-110 pounds, remove only 405-410 mL whole blood. If <100 pounds, accept only autologous donors and collect proportionately less. All blood removed includes sample tubes. The anticoagulant will be proportionally reduced for a reduced amount of blood in a standard collection bag. One venipuncture per unit, if more than one venipuncture then use a new container and donor set, unless SOPs allow a method to preserve sterility. All collection equipment must be single use and disposable. When the appropriate amount of blood is collected, then segments and specimen tubes are filled. Blood and components are placed on hold until serology and infectious disease testing are complete. Post-donation: observe donor, give post-donation instructions (remain sitting 10 minutes, drink more fluids than normal the next 4 hours, avoid alcohol & caffeine until you eat, don�t smoke for 30 minutes, if you feel dizzy lie down, if venipuncture starts to bleed apply pressure for 5-10 minutes, remove bandage after a few hours, call your physician if symptoms persist, resume normal activities when you feel alright, if you develop an illness or infection in the next few days or hepatitis-positive HIV test-AIDS in the next 12 months let collection site know, call collection site if you decide later for any reason that your blood should not be used for donation). Document adverse reactions or other incidents and notify donor of next acceptable donation. Donor blood products are quarantined if in doubt to assess purity, potency and safety with subsequent investigation, and evaluation for future donor deferral, disposition of components, and reports to FDA.

27. Adverse Donor Reactions Personnel should be trained to recognize and give initial treatment, including CPR. Emergency equipment available includes an emesis basin, towels, oropharyngeal airway, oxygen and mask, and emergency drugs as determined by the blood bank physician. Generally: Remove tourniquet and needle, move donor to private area, notify patient�s physician if patient does not recover rapidly after initial care.

28. Adverse Donor Reactions Nausea and vomiting: make donor comfortable and instruct to breath deeply and slowly,cold compresses to forehead or back of neck, turn donors head to the side, provide a receptacle and towels for cleaning, water to rinse mouth after vomiting. Hematoma at phlebotomy site: remove tourniquet and needle, apply firm pressure with sterile gauze for 7 to 10 minutes with arm above the heart level, may apply ice to about 5 minutes to site. If arterial puncture suspected, remove needle and apply firm pressure for 10 minutes with a pressure dressing afterward; check for a radial pulse and if no pulse palpable, call blood bank physician.

29. Adverse Donor Reactions Syncope (fainting, vasovagal syndrome): caused by psychologic or neurophysiologic response. Often the pulse slows significantly, in contrast to cardiogenic or hypovolemic shock. Sometimes the skin feels cold and blood pressure falls as low as 50 mm Hg. Symptoms include weakness, sweating, dizziness, pallor, loss of consciousness or bowel and bladder control, and convulsions. Fainting Rx: cold compress to donor forehead or back of neck, lie donor on back with legs above head level, loosen tight clothes, assure appropriate airway, monitor blood pressure-pulse-respiration until recovery. Prolonged hypotension may respond to normal saline infusion with blood bank physician approval. Convulsions: Call for help immediately, prevent donor from injuring themselves or others, assure adequate airway, notify blood bank physician.

30. Adverse Donor Reactions Hyperventilation: Due to loss of excessive carbon dioxide. Extreme anxiety may cause this with subsequent further anxiety, feeling of suffocation, or localized muscle spasm or tingling. Hyperventilation Rx: Divert donor�s attention with conversation to interrupt hyperventilation. Don�t give oxygen. If symptomatic, donor can rebreath carbon dioxide into a paper bag. Serious cardiac abnormalities: Call for emergency care immediately. If donor in cardiac arrest, start CPR and continue until help arrives.

31. Directed donations Recipients choose donors. Some states (Georgia) has law stating this must be offered in non-emergencies. Selection and testing same as allogeneic, but can give whole blood more than once every 8 weeks if physician certified donor is healthy. At MCG, the recipient is an MCG patient. Unused units are discarded and are not �crossed-over� into general inventory and used in other patients. There are circumstances when the recipient may receive random donor blood. Recipient-specific designated donations are from a specific donor to a specific recipient. Frequency of donation can be every 3 days as long as Hgb above minimum for allogeneic. Units are segregated from normal inventory, and tagged for recipient and from donor.

32. Autologous whole blood donor Collection is preoperative and perioperative (acute normovolemic hemodilution, intraoperative, or postoperative and these processes must comply with AABB standards). Selection of patients who can benefit is aided by considering anticipated surgical blood loss and the transfusion trigger (Transfusion trigger: clinical trials indicate even critical care patients can tolerate substantial anemia (hemoglobin 7 to 9 g/dL) with no apparent benefit from more aggressive transfusion therapy). A signed consent from the patient�s physician is required, and parent/guardian if indicated. Informed consent includes risks of frequent donation, complications, patient management and procedure process, alternatives, benefits, and notified infectious disease tests will be done and they will be notified of significant results. The same infectious disease tests are done as for any donation. Rigid criteria of donor selection not necessary, but need to reassess medical history, health and exam before each donation. No age limits (minors need parent�s consent). Asymptomatic HIV infection is a disability protected under the Americans with Disabilities Act and autologous service are offered to HIV positive patients. At MCG donor is still deferred when they may have bacteremia, active infection or HIV positive. An HIV positive blood test will disqualify the unit for transfusion and the donor�s physician will be notified it didn�t meet requirements for blood release. Uncomplicated pregnancy is not a contraindication. If a donor has a permanent deferral, or testing or history indicates deferral, and is an autologous donor, the product can be collected, and is labeled �biohazard�.

33. Preoperative autologous whole blood donor Preoperative autologous donation (PAD) Patient�s physician initiates written request, approved by transfusion service physician. Medical interview gives more attention to medications and health risk factors. For healthy stable patients in which transfusion is likely and may prevent adverse recipient reactions (example: useful for sickle cell patients with multiple alloantibodies). Administrative errors, volume overload and bacteria contamination are still a risk, but ABO and Rh type are tested at collection and confirmed before transfusion. Questions related to transfusion-transmitted disease is not necessary. Evidence of infection is still a contraindication. FDA infectious disease tests are not required unless the unit will be used for allogeneic donation or shipped to another facility. The donor is deferred from future donations if tests are positive. Minimum hemoglobin 11 g/dL and hematocrit 33%. �Standard� condition of one unit donated weekly may result in perioperative anemia, but aggressive phlebotomy (twice weekly for 3 weeks) starting 25-35 days before surgery shows enhanced erythropoiesis (exogenous erythropoietin is used in some countries). MCG SOPs states autologous donations must be at least 3 days apart and not within 72 hours of surgery. Supplemental iron (one ferrous sulfate or gluconate tablet per day) may be given before collection and collect far in advance to minimize anemia. Can store as liquid for 6 weeks or freeze for longer storage. Collected volume maximum is 10.5 mL/kg including test samples. The process must comply with AABB standards. Units must be properly labeled, for autologous use only, and test status identified. If components are made they must be similarly labeled. Cost of collection is higher than allogeneic (historical data shows only about 50% of units collected are transfused).

34. Acute normovolemic hemodilution (ANH) ANH removes whole blood (replaced with 3 mL crystalloid (1 mL colloid) per 1 mL blood) before anticipated blood loss. Blood stored in operating room and reinfused. ANH blood can be stored at room temperature for up to 8 hours from collection initiation (storage up to 24 hours with refrigeration), which preserves platelet and coagulation factor function. ANH is equivalent to PAD without wastage, or inventory and testing cost, and minimized possibility of clerical error or bacteria contamination. Must carefully monitor patient�s circulating volume and perfusion status during ANH (ANH decision is based on likelihood of needing a transfusion, and patient�s overall health, blood volume, hemodiluted hematocrit, and minimum preoperative hemoglobin of 12 g/dL). ANH program must comply with AABB standards, and be properly labeled and stored ( for autologous use only).

35. Intraoperative blood collection (IBC) Collecting and reinfusing blood, with or without processing (example: using microaggregate filters), lost during surgery (contraindicated with surgical procoagulant use). IBC collection devices that neither concentrate nor wash shed blood increase the risk for adverse events: air embolus, hemolysis, and coagulopathy. IBC may have a free hemoglobin level higher than allogeneic which may be nephrotoxic. Sometimes positive bacteria cultures are seen with IBC, but clinical infection is rare. Cell washing devices can provide up to 12 units of blood per hour. Most IBC programs use machines that produce concentrated washed saline suspended red cells with minimal platelets and coagulation factors. In IBC, survival of recovered blood cells is comparable to transfused allogeneic red cells. IBC blood from a sterile operating field, if not infused immediately, can be stored at room temperature for up to 6 hours of collection initiation, and up to 24 hours with refrigeration. Posttraumatic or postoperative shed blood shall be reinfused within 6 hours. The process must comply with AABB standards and IBC blood is labeled to identify patient, unit, expiration and for autologous use only. IBC studies show it�s value is primarily in patients with substantial blood loss. Blood loss must be sufficient to warrant the additional cost of processing technology compared to banked blood.

36. Postoperative blood collection (PBC) Recovery of blood from surgical drains and reinfusion with or without processing. PBC blood is dilute, partially hemolyzed, and defibrinated with high cytokine concentrations, accordingly some programs have an upper limit of 1400 mL of unprocessed blood reinfused. Theoretical concern of harmful material in recovered blood produced mixed reports of complications, and reports of no serious effects when a microaggregate filter was used. PBC use studies have shown mixed efficacy concerning the eventual need for allogeneic transfusions and perioperative hemoglobin level. Blood loss must be sufficient to warrant the additional cost of processing technology compared to banked blood. PBC blood must be used within 6 hours of collection initiation or discarded. Policies, procedures and labeling must be to AABB standards.

37. Apheresis donor The FDA has regulations, the AABB has voluntary standards, and the American Society for Apheresis has guidelines. Except for donation interval, the standards for allogeneic donor qualification apply to apheresis donor selection. ABO/Rh, antibody screen and tests for infectious disease is as for all blood components. Each unit is tested, unless repeat procedure for one patient, then disease markers can be check every 30 days. If red cells are visible in a not normally red cell containing unit, determine unit hematocrit, and if >2 mL of red cells include a donor blood sample for compatibility testing. A donor identification system will relate each donor to his blood, components, samples, and records. Automated cell-separators use centrifugation to make components and are used therapeutically. Whole blood has anticoagulant added as it is drawn from the patient, the desired fraction is diverted, the remaining elements returned usually continuously, or intermittently, to the donor with replacement fluid. Takes 30 minutes to several hours depending upon the procedure. Plasma is also collected through membrane filtration. Specific plasma constituents can be removed. Manual apheresis is seldom used and involves collection of blood in bags and centrifugation off-line.

38. Apheresis donor Components collected by apheresis require informed consent for the procedure. Replacement fluids: plasma, crystalloid, albumin and HES solutions. Normally normal saline will be used be used for volume replacement. Replacement fluid risks: plasma contains citrate (but maintains protein levels); crystalloids requires 2-3 volumes of plasma removed, is hypo-oncotic and has no coagulation factors or immunoglobulins (but is cheap, hypoallergenic, and no viral risk); albumin has no coagulation factors or immunoglobulins (but is iso-oncotic, and has no inflammatory mediators); and HES has long term residual levels, is contraindicated in renal failure and may produce coagulopathy (but is iso-oncotic, and has no inflammatory mediators). At any time during apheresis the intravascular volume deficit shall not exceed 10.5 mL/kg of donor�s weight.

39. Apheresis donor complications Risks are similar for whole blood donation (nausea, vomiting, faintness, dizziness, hematoma, seizures, blood loss, air embolus, infection). An anticoagulant will be used to prevent donor blood clotting. MCG uses ACD-A anticoagulant. Hypocalcemia usually doesn�t occur if donor has normal parathyroid and liver (metabolizes citrate) function. Hyperventilation, hypothermia, hypomagnesemia and plasma replacement fluid exacerbate citrate toxicity. Symptoms of decreased plasma ionized calcium are perioral paresthesia, tingling, and a feeling of vibration. If untreated, progresses to muscle twitching, chills, chest pressure, nausea, vomiting, hypotension, and dysrrythmia. Reduced ionized calcium reflects rate of citrate returned, ionized and bound calcium removed, and ionized calcium binding to albumin replacement fluid. Hypocalcemia is controlled by reducing the citrate, slowing the reinfusion rate, or administering calcium. Vasovagal and hypovolemic reactions are rare, and serious reactions are less common than whole blood donation. Hypovolemia/hypotension occur especially when extracorporeal volume > 15% of total body volume. Susceptible donors are children, elderly, neurology patients, anemic patients, and use of large extracorporeal volume intermittent flow devices. Also occurs with inadequate volume or protein replacement. Antihypertensive medicines especially ACE inhibitors with albumin replacement cause hypovolemic reactions and flushing and medicine should be discontinued 72 hours prior. Venous access complications (often require indwelling double lumen apheresis/dialysis catheter). Drug (especially albumin bound) levels are lowered, but few clinical data suggest adverse patient outcomes (but it is suggested to withhold drugs for 1 hour before apheresis).

40. Apheresis donor complications Cold fluid through a central venous line may cause dysrhythmias and fluid should be warmed. Intensive apheresis decreases levels of immunoglobulins and complement opsonins and may increase infection risk. Replacement plasma may transmit virus. The extracorporeal circuit may function improperly and mechanically hemolyse red cells. Hemolysis may also occur with incompatible replacement fluid (D5W to dilute albumin), or ABO discrepant plasma. Observe plasma collection lines for pink color. Respiratory distress during or soon after can occur from pulmonary edema, pulmonary embolus, anaphylaxis, and TRALI. Pulmonary edema can be from volume overload or cardiac failure with dyspnea, increased diastolic pressure, and characteristic chest x-ray. Acute pulmonary edema can also arise from immunologic damage to alveolar capillaries, or a vasoactive substance in plasma. FFP as a replacement fluid may also activate complement and cause allergic reactions with urticaria, oral mucosa swelling and bronchospasm which usually responds to antihistamines and corticostroids. Ethylene oxide gas that sterilizes disposable plastic apheresis kits may cause a primarily ocular (periorbital and conjunctival edema, and tearing) allergic reaction in sensitized donors. Fatalities during apheresis is rare (from 3:10,000 to 1:500) with most due to cardiac dysrhythmias or acute pulmonary edema or ARDS during or soon after. Even more rarely anaphylaxis, vascular perforation, hepatitis, sepsis, thrombosis, and hemorrhage.

41. Apheresis donor After 48 hours the donor may donate blood for an apheresis product that returns the red cells. The interval of donor cytapheresis procedures for platelets, granulocytes, and leukocytes shall be at least 2 days, with a procedure maximum of 2 times in 7 days, and up to 24 times per year ( > 48 hours from last plasma-/cytapheresis before whole blood donation). Cytopenias shall be tested for appropriately. If a unit of whole blood is donated, 8 weeks shall elapse before plateletpheresis, granulocytpheresis / leukopheresis unless the extracorporeal volume is less than 100 mL. Any donor who has not had red cells returned from whole blood, or apheresis, shall not have apheresis for 8 weeks, unless red cells lost was < 200 mL. A two unit red cell apheresis collection donor shall be deferred for 16 weeks. The volume of red cells removed for apheresis donors shall not result in a predicted donor hematocrit of < 30% or hemoglobin < 10 g/dL after volume replacement with saline. The procedure is limited to larger people with higher hematocrits: males > 130 pounds and 5 ft. 1 inch, and females > 150 pounds and 5 ft. 5 inch; hematocrit > 40% for both.

42. Apheresis donor Plateletpheresis can collect a large number of platelets from an individual and reduce allogeneic donor exposures for patients. An HLA matched or crossmatched plateletpheresis donor may be selected for an alloimmunized patient refractory to random allogeneic platelets. Apheresis platelets can be donated as much as twice per week or up to 24 times a year. If plateletpheresis is more than every 4 weeks, a platelet count of > 150,000 per microliter is required to be checked before or after the procedure to qualify for the next procedure. An 8 week platelepheresis interval is necessary, if red cells aren�t returned during plateletpheresis. If aspirin is taken, 36 hour deferral for plateletpheresis.

43. Apheresis donor Leukopheresis: the collection facility shall have criteria for administration and properties of ancillary agents used, such as maximum cumulative sedimenting agents over a given time. Drugs used for leukopheresis shall not exacerbate a donor�s medical condition. Leukopheresis testing requires ABO/Rh, antibody screen, and infectious disease testing. Red cells should be ABO compatible and ideally D negative for D negative recipient, and if > 2 mL then component is crossmatched. In alloimmunized recipient, leukocytes should be HLA matched.

44. Apheresis donor Granulocyte transfusion indications unclear (clinical results mixed). Effectiveness depends on adequate dose (> 10 billion granulocytes/day), and granulocytes crossmatch compatibility. Septic infants have success due to large dose for their small size and the lack of HLA alloimmunization. Granulocytes transfusion risks: HLA alloimmunization (with HLA incompatible granulocytes sequestered in the lungs and respiratory distress), GVHD, and CMV infection. To collect 10 billion granulocytes per day requires administration of drugs or adjuvants before leukapheresis and requires informed consent. Hydroxyethyl Starch (HES) is a red cell aggregating/sedimenting agent that minimizes inevitable red cells collected and enhances granulocyte collection (HES also produces volume expansion). Corticosteroids double circulating granulocyte by mobilizing the marginal pool (steroids may exacerbate hypertension, diabetes and peptic ulcers). Hematopoietic growth factors, specifically granulocytes colony stimulating factors, increase granulocyte yields and are well tolerated. Growth factors alone can increase collection to 40-80 billion granulocytes per apheresis. Granulocyte function deteriorates during storage so store for no longer than 24 hours at 20-25 Celsius without agitation.

45. Apheresis donor See the discussion of Hematopoietic Progenitor Cells for more details of this topic. Hematopoietic stem cells are self renewing and give rise to a complete hematopoietic graft. Hematopoietic progenitor cells are not self renewing and commited to give rise to a blood cell lineage. Both cell types are often referred to as hematopoietic progenitor cells (HPCs). HPCs are collected with cytapheresis for bone marrow reconstitution. HPCs are then cryopreserved and, after treatment of the patient, infused. Sources of progenitor cells include marrow, peripheral blood, umbilical cord blood, and fetal liver (experimental). Historically marrow was the primary source of hematopoietic cells; however, peripheral blood progenitor cell (PBPC, which contain stem cells and progenitor cells) transplants are more common for adult autologous transplantation. Mobilized collections of autologous PBPCs results in earlier engraftment. Umbilical cord blood transplants show promise for pediatric patients. PBPC collection involves mobilization of hematopoietic cells from the marrow to the peripheral blood by hematopoietic growth factors where they are collected by leukapheresis. PBPC collection has no anesthesia risk, less invasive and fewer tumor cells than marrow harvest. Allogeneic HPC transplants have the difficulty of finding an HLA match, rejection and GVHD, but the recipient may benefit from a graft versus tumor effect. In the case of an identical twin donor the graft is called syngeneic. Autologous grafts are usually to treat malignant disease of the marrow and metastatic or recurrent solid tumors.

46. Apheresis donor Plasma intended for transfusion will have same testing requirements as red cell components. Plasmapheresis donors will have blood tests for a serologic syphilis test, total protein and immunoglobulin composition at the first medical exam, and every 4 months if they are to be a large volume donor (total annual volume >12 L, 14.4 L if over 175 pounds) or frequent donor. Frequent/serial plasmapheresis indicates less than every 4 weeks, and the FDA requires donor testing and close monitoring, and include a total protein of no less than 6 gm/dL. Red cells losses are to be < 25 mL/week, and < 200 mL/8 weeks, if red cells not returned during apheresis, then hemapheresis or whole blood donation is deferred for 8 weeks. Infrequent/occasional plasmapheresis indicates not less than every 4 weeks. Donor selection and monitoring is the same as whole blood. During a manual plasmapheresis, no more than 500 mL of whole blood shall be removed (600 mL if >175 pounds), plasma separated immediately and the maximum number of red cells returned. In any 2 day period up to 1000 mL of whole blood may be removed (1200 if >175 pounds). In any 7 day period up to 2000 mL of blood may be removed (2400 mL if >175 pounds). Plasma collections shall occur a maximum of twice in 7 days and the collection interval shall be at least 2 days. AABB standard is intravascular deficit must be <10.5 mL/kg at all times.

47. Questions in Transfusion Medicine Self Assessment and Review, proceed with slide show for answer Which of the following donors is eligible to donate?