- Email: [email protected]
Blood collection techniques
Blood Collection Techniques Letty Kotwas, Ann C. Gilfillan, Natalie Gerace, and Pamela Z. Leach
T IS OFTEN the expectation of patients, family, and friends that the nurse is a resource of knowledge, someone who facilitates understanding. What better profession, then, can understand the value of blood and blood components, and the specific responsibilities family members and friends have in being blood donors and how they may contribute to a safe and effective blood supply?
I
OVERVIEW
Today, blood banking in the United States is generally a well-organized and standardized industry that is heavily regulated by the federal government and some states. The federal government regulates the blood banking industry under Title 21, Code of Federal Regulations, which places stringent requirements on collection, testing, storage, and distribution of blood and blood components. Approximately 13.5 million units of blood are collected each year throughout the nation, and most of these units are separated into components. In the treatment of patients, red cells, platelets, plasma, and cryoprecipitated antihemaphilic factor are the most commonly used. The fact that donating blood could be a physically threatening experience has all but been forgotten as result of significant advances made in donor protection over the last 50 years. These developments include the establishment of health criteria that must be met by prospective donors prior to their being accepted for donation; availability of sterile disposable polyvinyl blood containers; use of calibrated blood container scales for measuring the amount of blood being collected; improved training and education programs for individuals engaged in the performance of blood collection; and, very importantly, development of educational materials for blood donors. Polyvinyl blood containers, which allow blood to be collected by gravity have, to a large degree, replaced glass bottles. These are quite a progression from the blood bank equipment described by August Korkosz, MD, (Ellis Hospital, Schenectady, NY) in a 1942 article: Seminars in Oncology Nursing, Vol 6, No 2 (May). 1990: pp 109-116
The donor sets consisted of a 500-mL flask with 50 mL of 3% sodium citrate solution in chemically pure water, a bakelite cap, a rubber bulb, a short length of transparent tubing, a glass adapter, and a no. 19 needle. The rubber bulb provides the occasional suction necessary for drawing b l o o d . . . Meticulous care in the cleansing and preparation of equipment is indispensable . . . A responsible nurse is a major necessity for the prevention of reactions caused by unclean apparatus . . . Until recently rubber tubing for donor and recipient sets was used six times and discarded. The war situation has necessitated using the tubing until it is obviously unfit for u s e )
Later the United States began using commercially prepared glass bottles with pyrogen-tested anticoagulant. Glass broke, the platelets stuck to the side of the bottle, and the potential for air embolism created by positive pressure when the collecting bottle was in the inverted position was a serious risk.2 Individuals who donated blood during the period of World War I were thought to be able to donate 700 to 1,000 mL of blood (now limited to 450 -+ 45 mL). Donor criteria established at that time were limited only to preventing those with malaria, syphilis, and other infectious diseases from giving blood. There was no emphasis on measures to protect the well-being of the donor. Today, donor criteria have been expanded significantly to include both the donor and the recipient of blood and blood components. The development of solutions that prevented coagulation of collected blood and provided glucose for the preservation of blood cell metabolism, together with increased donor health criteria and requirements for routine laboratory testing of donor blood, led to organized blood banking in the early From American Red Cross Blood Services, National Headquarters, Washington, DC. Letty Kotwas, RN, MS, CNA: Associate, Regulatory Affairs; Ann C. Gilfillan, RN, MS: Associate, Operations; Natalie Gerace, RN: Consultant, Regulatory Affairs; Pamela Z. Leach, RN, MBA: Manager, Good Transfusion Practices, American Red Cross Blood Semices, National Headquarters, Washington, DC. Address reprint requests to Letty Konvas, RN, MS, CNA, Regulatory Affairs, American Red Cross Blood Services, National Headquarters, 1730 E St NW, Washington, DC 20006. © 1990 W.B. Sa,mders Company. 0749-208t19010602-0004505.0010
109
110
KOTWAS ET AL
1940s. This practice of transfusing stored donor blood began to take precedence over that of direct donor-to-patient transfusions.3 COORDINATION OF BLOOD RESOURCES
Following World War II, technology continued to evolve and blood transfusions became routine practice in the treatment of patients. A new medical speciality, "Transfusion Medicine,"4 was established. It became increasingly evident that the technology associated with transfusion medicine was growing rapidly and that coordination of this valuable resource, blood, was becoming essential. In 1973, the federal government established the National Blood Policy (NBP), with four major goals: to improve supply, quality, accessibility, and efficiency of this nation's blood resources. Several policies evolved from these goals, including efforts toward development of an all-volunteer donor base (available data suggested that blood from paid donors presented increased risk of transmission of hepatitis); regionalization and national resource sharing (data indicated that the blood supply was sometimes inadequate, uneven, and a financial burden); and education (inappropriate use of blood was identified), s The response to these policies has been generally positive. Today, commercial whole blood collection has all but been eliminated in favor of an all-volunteer blood collection system6; the major blood collection organizations in the country have resourcesharing programs in operation. Education of health professionals in the appropriate use of blood and blood components, however, remains a challenge and cause for concem. TRANSFUSION SERVICES AND REGIONAL BLOOD SERVICES
A transfusion service, often hospital based, tests the blood of the intended recipient and is concemed with the transfusion of donor blood and its components. The transfusion service sets standards and supervises the administration of blood in that facility. Those transfusion services that routinely obtain blood from a regional blood service often participate in the governance of the regional program, and share in the combined resources of the region. A regional blood service, such as community blood banks or the American Red Cross, is respon-
sible for providing blood services to a defined geographical area. These services included recruitment of suitable donors, collection of blood, laboratory testing of donor blood samples, preparation of components, and storage and distribution of blood products. Services also include participation in a national resource-sharing program to supplement the regional supply if a shortage should occur. Some regional blood centers may have additional specialized services such as a reference laboratory for assisting in the identification of special antibodies and selection of compatible units for patients having such antibodies; a human leukocyte antigen (HLA) laboratory to achieve the best possible match of platelet donor to platelet recipient; donor apheresis programs for special collections of platelets and white cells; intraoperative autologous transfusion services; a bone marrow donor registry; and small transfusion services. While blood banking agencies differ in philosophies, they are as one regarding sharing the blood resource nationwide. A common objective prevails: those who need blood transfusions shall receive them. 7 REGULATORY AFFAIRS
Blood is defined as both a drug and a biologic by the Food and Drug Administration (FDA). Hospital transfusion services, regional blood centers, and commercial plasmapheresis centers involved in the collection, processing, testing, storage, distdbution and/or transfusion of blood and blood components are required to register annually with the FDA. Furthermore, if the facility intends to ship blood across state lines, a US license is required. 8 The FDA conducts inspections of licensed facilities which are required to report errors, accidents, and fatal complications of blood collection or transfusion. A number of other federal, state, and peer review organizations are also involved in the inspection of blood banks. Some of these organizations are: Health Care Financing Administration (HCFA), Centers for Disease Control (CDC), Occupational Safety and Health Administration (OSHA), College of American Pathologists (CAP), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), American Association of Blood Banks (AABB), and some state health departments. 9 States became more active in the 1970s and again in the 1980s when it
BLOOD COLLECTION TECHNIQUES
was discovered that acquired immunodeficiency syndrome (AIDS) could be transmitted by transfusion. The states have a promulgation of regulations of varying degrees and complexity. VOLUNTARY PROFESSIONAL BLOOD BANKING ORGANIZATIONS
There are three major blood banking organizations in the United States composed of members from transfusion services, regional blood centers, or a combination of both: the American Red Cross, the American Association of Blood Banks, and the Council of Community Blood Centers (Table 1). The American Red Cross (ARC), a notfor-profit organization, and the National Research Council began the first national blood supply operation to support the war effort in 1941. Red Cross chapters initiated a program to establish regional blood centers throughout the United States in 1947. Today, the 56 Red Cross regional blood services operate under one FDA license and under blood services directives issued by the Red Cross national headquarters. Internal audits are performed to ensure that the regional blood services comply with Red Cross policies and directives and federal regulations. The Red Cross collects over 50% of the nation's blood supply and cooperates with the AABB and the Council of Community Blood Centers in the standardization of blood banking activities. The AABB is a not-for-profit organization founded in 1947. The Standards For Blood Banks and Transfusion Services published by this organization are designed to improve the quality and safety of blood transfusion, and are regarded as authoritative by blood bankers and transfusion serTable 1. Major Voluntary Professional Blood Banking Organizations American Red Cross Blood Services National Headquarters 1730 E St, NW Washington, DC 20006 202-737-830rj American Association of Blood Banks 1117 North 19th St, Suite 600 Arlington, VA 22209 703-528-8200 Council of Community Blood Centers 735 15th St NW, Suite 700 Washington, DC 20005 202-393-5725
111
vices worldwide. AABB conducts voluntary inspections for their member institutions and for facilities desiring accreditation. The Council of Community Blood Centers (CCBC) was formed in 1962 by community blood centers. This organization addresses the management aspects of community and regional blood services, and encourages informational exchange and educational efforts. Together, AABB and CCBC fulfill almost 50% of the nation's blood needs. Although the three organizations have differing philosophies, they all cooperate in a strong effort to maintain a safe and available blood supply throughout the nation. 9 VOLUNTEER BLOOD DONATION
Volunteer blood donors ale recruited to donate their blood in a variety of settings, such as community blood drives, on a self-contained "bloodmobile" vehicle, at employer-sponsored blood drives, or hospital-based blood collections. Donors are informed about each step of the donation process (Table 2), about laboratory tests that will be performed on their blood and the notification process if any test results have an implication for their health, and about the physical side effects that might occur during or after the donation. Federal guidelines require that each prospective donor be informed about AIDS, including its signs and symptoms, behaviors that place people at risk for developing AIDS, and transmission of human immunodeficiency virus (HIV) through blood transfusion. Most blood collection agencies provide information that donors are required to read before the health history process is begun. After reading the information, people who recognize that they are at risk for developing AIDS can self-exclude themselves from donation by simply leaving the donation site. Those who feel they cannot leave without drawing attention to themselves can ask the health history interviewer to exclude them from donation. Each donor undergoes a limited health assessment (Table 3), including a health history evaluation, vital sign determination, and hemoglobin estimation, which is documented on a permanent record. Only donors who meet all the established criteria may be accepted for donation, and each is required to sign a statement attesting to the truthfulness of the information provided.
KOTWAS ET AL
112 Table 2. Steps in Donating Blood
Table 3. Quick Check of Criteria for Donor Selection
Registration Information to donors about: Donor and recipient safety Potential adverse reactions Tests to be performed Post-donation instructions Signs and symptoms of AIDS Local telephone number of donation facility Health assessment Vital signs Hemoglobin estimation or hemoglobin-hematocrit determination Review of questions regarding donor and recipient safety Self-exclusion procedure (private location): Donor confidentially indicates whether his or her donation is safe for transfusion Blood pack assembly and distribution Plastic blood container selected by staff for this donation Labeled with unique number Blood donation Final review of donor history responses, check to ensure same unique numbers on bags, tubes, and paperwork Arm inspection (drug abuse, skin disease) Vein selection and aseptic arm prep Phlebotomy and donor observation Blood mixed with anticoagulant Discontinue venipuncture; apply pressure to venipuncture site for 2-3 min Instructions: replace fluids, keep pressure dressing on for 4 h; avoid strenuous exercise, smoking, and alcohol; call us if problem develops Dangle, observe for orthostatic hypotension, venlpuncture site bleeding Post-donation recovery Refreshments and donor observation for 15 rain Followup On adverse reactions Notify donor of any positive test results that would be harmful to their health
On day of donation (55 days required between donations): Age: Between 17 and 66 yr. State law prevails on minimum age. Blood Service physician may accept person over age 66. General appearance: The potential donor must appear healthy. Weight: Minimum 110 lb. Pulse: Usually between 50 and 100. Athletes' may be lower. Temperature: Oral, no higher than 37.5°C. Blood Pressure: Systolic limit, 180; diastolic limit, 100. Further evaluation may be required. Hemoglobin: Current lower limit is 12.5 gldL for females, 13.5 gldL for males. Pregnancy: Ordinarily excluded for 6 weeks after delivery. Travel: International travel to malarial areas, other highrisk countries for AIDS is cause for deferral. Hepatitis: Known history of hepatitis A, B, or C. Positive hepatitis B surface antigen (HbsAg)~ permanent deferral. Blood transfusion during the last 6 months--temporary deferral. History of jaundice requires further evaluation. AIDS: Positive HIV test, AIDS-related complex, Kaposi's sarcoma--permanent deferral. Exposure to AIDS must be evaluated. Medications: The reason for taking the medication will usually determine eligibility. Illness: Diseases of the heart, lungs, liver; a history of abnormal bleeding or cancer is usually cause for deferral. Further evaluation by a physician may be necessary. Immunizations and vaccinations: Killed virus, toxoids, bacterial, or rickettsial OK if symptom free and feeling well. Attenuated viral vaccine, 2-week deferral Rubella, 1-month deferral Rabies, 1-year deferral
Blood collecting agencies are responsible for the permanent identification of the blood donor with the donated blood throughout all steps in the manufacturing process. This process ensures that each unit of blood and each of its components can be traced to its source. Unique labels identify each unit of blood. The donation process itself takes approximately 15 minutes. Prior to venipuncture, the phlebotomist inspects the antecubital areas of both arms, selects a suitable vein, and prepares the venipuncture site with an aseptic solution to prevent contamination of the blood. The phlebotomy is performed with a large-bore (16-gauge) needle, and approximately 450 mL of whole blood is collected into the sterile blood container. On completion of the donation, laboratory testing samples are collected, the phlebotomy is discontinued, and the
All eligibility questions relate to either the protection of the donor or the protection of the recipient.
plastic tubing is sealed to prevent contamination of the collected blood. The needle used in the phlebotomy is removed from the vein and placed in a container for safe biohazard disposal. The blood is placed in a refrigerator or portable cooler to await processing into blood components. Following the donation, the donor is observed for any untoward reaction and given verbal instructions for post-donation care. Refreshments are offered and the donor is asked to remain on site for about 15 minutes, until he or she has adjusted to the blood loss. 1o While the risks of donating blood are generally minor, a small number of people may experience syncope, bruising at the needle site, and nausea. A fewer number may faint and, on rare occasions a donor may experience tetany and convulsion. Four hundred fifty milliliters of blood withdrawn from a 110-lb donor is approximately
BLOOD COLLECTION TECHNIQUES
113
12.7% of the donor's total blood volume (TBV); FDA limit is 15% TBV. Individuals who have been accepted as blood donors are required to perform a confidential unit exclusion procedure. They must review in private the printed material that outlines risk behaviors associated with AIDS, and indicate, either by check mark or selection of a bar-code label, if the donation is or is not safe to be transfused to another person. If the donor indicates that the unit (identified by number only) is not suitable for transfusion or fails to complete the form, the unit of blood must be destroyed. APHERESIS
Apheresis, a Greek word meaning "to remove" or "to take away," is used in blood banking to describe a process whereby whole blood is collected from a donor, the desired components removed, and the remaining portions of blood returned to the donor. There are two main types of
,
Fig 1. Baxter FenwalCS-3000 blood cell separator (Baxter Healthcare Corp, Fenwal Division, Deerfield, IL).
apheresis procedures: plasmapheresis and cytapheresis. Plasmapheresis refers specifically to the removal of plasma. Cytapheresis is a general term used to describe the removal of cellular components, such as platelets (plateletpheresis) and white cells (leukapheresis) (see Fig 1). Although apheresis procedures can be performed manually, the evolution of machinery since the 1950s allows the process to be done automatically. Apheresis methods have the advantage of providing therapeutic doses ofplatelets (3 to 7 × 1011) and granulocytes (1 to 2 × 101°) from one donor; recipients are exposed to fewer donors, potentially reducing the risk of transfusion reactions and transmission of infectious disease. The various components of blood, including red cells, platelets, white cells, and plasma have differing specific gravities. These differentiating densities permit viable separation of blood components by centrifugation. Chemical, radiologic, and immunologic treatments used in cancer therapy
!
114
can compromise a patient's bone marrow and result in pancytopenia. Before platelet separation techniques were perfected, many patients with thrombocytopenia died of hemorrhage. As separation techniques and cancer therapies advanced through the 1960s, control of thrombocytopenic hemorrhage became more effective. Donor Requirements In general, apheresis donors must meet the same selection criteria as whole blood donors. All infectious-disease deferral procedures as described earlier are followed. In addition, plateletpheresis donors are questioned about whether they have ingested medications containing aspirin, as it inhibits platelet aggregation. An evaluation of adverse reactions to previous apheresis or whole blood donations is made to detect possible allergies or fluid retention caused by medications or solutions used in these collection methods. A platelet count is performed to determine eligibility for donation. It is generally contraindicated to accept a donor with a platelet count of < 150,000/l_tL. Additional laboratory monitoring of apheresis donors is necessary for those who donate more frequently than whole blood donors (every 56 days). Frequent donors are required to have a serum protein level above 6.0 g/dL and IgM and IgG levels within normal limits. White blood cell counts, including differential, are also monitored. Total red cell loss (combined whole blood, apheresis donations, and laboratory samples) is limited to the equivalent in maximum whole blood donations per year. Plasma loss is limited to the World Health Organization standard of 15 L/yr. Donations may occur up to twice per week, but no more frequently than every 48 hours; plateletpheresis is currently limited to 24 times per year. ~ Most organizations limit the number of leukapheresis donations due to the theoretical risk of lymphocyte depletion. Apheresis products may be collected to provide platelet concentrates for hospital inventories, or donors may be specifically selected on the basis of their human leukocyte antigen (HLA) type. Informed consent is obtained for all apheresis procedures; it includes a description of the procedure and the risks involved, acknowledgment that the long-term effects of the loss of lymphocytes is unknown, and a statement about donors' right to ask questions or withdraw from the procedure at any time.
KOP,NAS ET AL
Instrumentation The focus of blood banking is gradually shifting from manual separation of components obtained from whole blood to specific donors and blood obtained by automated blood collection methods. The first apheresis instrument, developed in the 1950s, enabled the separation of plasma from various formed elements of blood. Significant advances in cytapheresis over the last 20 years have led to computerized instruments capable of more precise packing of cells and higher-yield products. Current automated instruments use specially designed disposable plastic harness sets with one or two large-bore, 16-gauge needles for one-arm or two-arm procedures. An anticoagulant solution is added automatically at a specific ratio to the volume of blood collected to keep the blood from clotting during the process. Approximately 5,000 mL of donor blood flows through the disposable software in about 1 to 1I/2 hours (needle in to needle out). To obtain different components the donor's blood enters a chamber, bowl, or channel. The centrifugal force separates the different components, and strategically placed tubes remove the desired component, which flows into a plastic product container. Depending on the instrument used, approximately 250 mL to 450 mL of donor blood is extracorporeal at any given time. Because the therapeutic effects of granulocyte therapy are not well defined, the collection of granulocytes (leukapheresis) is not routinely prescribed, t2 Potential Donor Reactions In addition to potential adverse reactions associated with whole blood donations, such as syncope and nausea, apheresis donors may experience reactions as a result of the cooling of the processed blood or infused solutions and/or medications. Most reactions are mild and can be alleviated if the procedure is temporarily stopped. Apheresis donors are exposed to the same risk of citrate toxicity as blood recipients who have multiple and rapid transfusions. The reinfusion of citrated blood accompanying transient hypocalcemia may cause various paresthesias. Often paresthesias are described as circumoral or facial numbness or tingling, coolness of the throat, or a sensation of the donor chair vibrating. The donor may feel cold and begin to shiver. These symptoms are transient and can be reduced by slowing the reinfusion of blood
BLOOD COLLECTION TECHNIQUES
to the donor and allowing the liver to metabolize the citrate. Visual checks of the harness for flow restrictions and/or damage to the tubing during setup and throughout the procedure are essential to prevent air from entering the harness. 13 Standard operating procedures for both life-threatening and non-life-threatening situations are required. Because of the additional potential risks involved in apheresis procedures, the availability of medical assistance is warranted. AUTOTRANSFUSION AND CELL SAVING
The fear of transfusion-transmitted infections, particularly AIDS and hepatitis, has led to a renewed interest in the use of a person's own blood. Autologous blood has long been known to provide the safest and most compatible transfusion possible, but only recently has become a widely accepted transfusion alternative.14 Autologous blood programs and services, which collect and process one's own blood preoperatively, intraoperatively, and/or postoperatively, have grown in number and scope throughout the country.
Preoperative Autologous Donation Donating blood in advance of scheduled surgery for one's own use during a surgical procedure is the most common form of autologous donation. The number of units to be collected depends on the type of surgical procedure scheduled and the potential blood loss. Many patients begin the process up to 6 weeks before surgery and are able to donate 5 units of blood to be stored in the liquid state. Blood must be stored frozen if collected too far in advance of the date needed. Medical eligibility criteria for autologous donors are less stringent than the requirements for volunteer blood donors because receiving one's own blood adds no new risk of blood-transmitted disease. A person with a history of malignancy is a prime example of someone who may be precluded from donating blood for someone else but not for himself. Autologous donors are not held to the same strict weight or age requirements, which allows children and underweight donors to donate blood for themselves. Donors who might be considered high risk, such as those with a history of coronary artery disease, or pregnant women, are also considered candidates for autologous donation, depending on physical evaluation. In addition, autologous donors are permitted to have their blood
115
collected at shorter intervals than individuals donating for others.
Normovolemic Hemodihaion Acute normovolemic hemodilution provides patients another autologous option, especially if the patient is unable to donate blood preoperatively (eg, before bypass surgery), or if there is not sufficient time to predonate. Performed in the operating room immediately after the induction of anesthesia, hemodilution involves the withdrawal of I or 2 units of the patient's blood. A crystalloid or colloid solution is simultaneously infused during the phlebotomy to maintain the patient's circulating volume. The fresh, whole blood is generally returned to the patient in the operating room after bleeding is brought under control.
hztraoperative Autologous Transfusion Intraoperative autologous transfusion (IAT), also referred to as " c e l l salvage" or "cell saving," offers still another autologous option. IAT is a procedure whereby blood normally lost during the course of surgery is saved and subsequently returned to the patient. IAT devices range from sterile hand-held canisters that provide gross filtration of blood and can simply be inverted for reinfusion, to more technologically sophisticated devices capable of collecting, separating, and washing the blood. These latter autotransfusion machines have been used in cardiac and vascular surgery for more than 15 years, and more recently have gained widespread acceptance in transplantation and major orthopedic procedures. Suspicion of a malignant lesion is generally considered a contraindication for IAT because of the potential collection of malignant cells and subsequent intravenous transfusion, although this is still somewhat controversial. 15
Postoperative Autologous Collection Blood loss following cardiac surgery and certain orthopedic procedures, such as total knee replacement, can be significant. Collection devices are available to salvage blood from the pleural space or surgical wound for subsequent reinfusion. The sterile collection canisters are connected to the drains in the operating room. Depending on the surgeon's preference, the blood may be washed before reinfusion or reinfused directly from the collection device.
116
KOTWAS ET AL SUMMARY
To date, there is no substitute for human blood. It is the only source material for the manufacture of cellular components and fractionated plasma products. Whole blood donation has transversed many
risk barriers experienced in early collections and has become a relatively minor and uncomplicated procedure. Blood collection techniques have made significant advances, particularly in recent years, making blood components an essential part of specific cancer treatments.
REFERENCES
1. KorkoszA: The Blood Bank. Davis NursingSurvey, vol 6. Philadelphia,PA, Davis, 1942, p 371 2. GreenwaltTJ: An autobiographicalperspective of blood banking, 1946 to 1988. TransfusionMed 29:250, 1989 3. Winthrop MM: Blood Pure and Eloquent. New York, NY, McGraw-Hill, 1980, p 691 4. KleinHG: Transfusionmedicine:The evolutionof a new discipline. JAMA 258:2108-2109, 1987 5. SchmidtPJ: Nationalblood policy, 1977: A study in the politics of health, in Brown EB (ed): Progress in Hematology, vol 10. Philadelphia,PA, Grune & Stratton, 1977, p 169 6. US Congress, Office of TechnologyAssessment: Blood Policy and Technology. Washington,DC, OTA-H-260,publication 85-601151, 1985, pp 25-108 7. Food and Drug Administration:Title 21, Code of Federal Regulations. Washington,DC, Departmentof Health and Human Services, parts 600 and 601, 1989 8. Pittiglio DH: Modern Blood Banking and Transfusion Practices. Philadelphia,PA, Davis, 1983, pp 284-286
9. RutmanRC, Miller WV: TransfusionTherapy Principles and Procedures (ed 2). Rockville, MD, Aspen, 1985 10. American Red Cross Blood Services Directives. 5.17, Blood Collection Procedures; 5.29, Donor Processing and Management. Washington, DC, American Red Cross, 1981 and 1988 11. Food and Drug Administration,Division of Blood and Blood Products: RevisedGuidelinesfor the Collectionof Platelets, Pheresis Preparedby AutomatedMethods. Bethesda, MD, FDA, 1988 12. Snyder EL, KennedyMS, BlumbergN: Blood transfusion therapy: A physician's handbook (ed 2). Arlington, VA, American Associationof Blood Banks, 1987 13. Kotwas L: Pheresis Donor Reactions and Complications, Prevention,Recognition,and Management:Fundamentals of a Phereis Program. Washington,DC, AABB, 1979, pp 63-76 14. PopovskyMA, Devine PA, Taswell HF: Intraoperative autologous transfusion.Mayo Clin Proc 60:125-134, 1985 15. Glover JL, Broadie TA: Intraoperativeautotransfusion. World J Surg 11:60-64, 1987
T IS OFTEN the expectation of patients, family, and friends that the nurse is a resource of knowledge, someone who facilitates understanding. What better profession, then, can understand the value of blood and blood components, and the specific responsibilities family members and friends have in being blood donors and how they may contribute to a safe and effective blood supply?
I
OVERVIEW
Today, blood banking in the United States is generally a well-organized and standardized industry that is heavily regulated by the federal government and some states. The federal government regulates the blood banking industry under Title 21, Code of Federal Regulations, which places stringent requirements on collection, testing, storage, and distribution of blood and blood components. Approximately 13.5 million units of blood are collected each year throughout the nation, and most of these units are separated into components. In the treatment of patients, red cells, platelets, plasma, and cryoprecipitated antihemaphilic factor are the most commonly used. The fact that donating blood could be a physically threatening experience has all but been forgotten as result of significant advances made in donor protection over the last 50 years. These developments include the establishment of health criteria that must be met by prospective donors prior to their being accepted for donation; availability of sterile disposable polyvinyl blood containers; use of calibrated blood container scales for measuring the amount of blood being collected; improved training and education programs for individuals engaged in the performance of blood collection; and, very importantly, development of educational materials for blood donors. Polyvinyl blood containers, which allow blood to be collected by gravity have, to a large degree, replaced glass bottles. These are quite a progression from the blood bank equipment described by August Korkosz, MD, (Ellis Hospital, Schenectady, NY) in a 1942 article: Seminars in Oncology Nursing, Vol 6, No 2 (May). 1990: pp 109-116
The donor sets consisted of a 500-mL flask with 50 mL of 3% sodium citrate solution in chemically pure water, a bakelite cap, a rubber bulb, a short length of transparent tubing, a glass adapter, and a no. 19 needle. The rubber bulb provides the occasional suction necessary for drawing b l o o d . . . Meticulous care in the cleansing and preparation of equipment is indispensable . . . A responsible nurse is a major necessity for the prevention of reactions caused by unclean apparatus . . . Until recently rubber tubing for donor and recipient sets was used six times and discarded. The war situation has necessitated using the tubing until it is obviously unfit for u s e )
Later the United States began using commercially prepared glass bottles with pyrogen-tested anticoagulant. Glass broke, the platelets stuck to the side of the bottle, and the potential for air embolism created by positive pressure when the collecting bottle was in the inverted position was a serious risk.2 Individuals who donated blood during the period of World War I were thought to be able to donate 700 to 1,000 mL of blood (now limited to 450 -+ 45 mL). Donor criteria established at that time were limited only to preventing those with malaria, syphilis, and other infectious diseases from giving blood. There was no emphasis on measures to protect the well-being of the donor. Today, donor criteria have been expanded significantly to include both the donor and the recipient of blood and blood components. The development of solutions that prevented coagulation of collected blood and provided glucose for the preservation of blood cell metabolism, together with increased donor health criteria and requirements for routine laboratory testing of donor blood, led to organized blood banking in the early From American Red Cross Blood Services, National Headquarters, Washington, DC. Letty Kotwas, RN, MS, CNA: Associate, Regulatory Affairs; Ann C. Gilfillan, RN, MS: Associate, Operations; Natalie Gerace, RN: Consultant, Regulatory Affairs; Pamela Z. Leach, RN, MBA: Manager, Good Transfusion Practices, American Red Cross Blood Semices, National Headquarters, Washington, DC. Address reprint requests to Letty Konvas, RN, MS, CNA, Regulatory Affairs, American Red Cross Blood Services, National Headquarters, 1730 E St NW, Washington, DC 20006. © 1990 W.B. Sa,mders Company. 0749-208t19010602-0004505.0010
109
110
KOTWAS ET AL
1940s. This practice of transfusing stored donor blood began to take precedence over that of direct donor-to-patient transfusions.3 COORDINATION OF BLOOD RESOURCES
Following World War II, technology continued to evolve and blood transfusions became routine practice in the treatment of patients. A new medical speciality, "Transfusion Medicine,"4 was established. It became increasingly evident that the technology associated with transfusion medicine was growing rapidly and that coordination of this valuable resource, blood, was becoming essential. In 1973, the federal government established the National Blood Policy (NBP), with four major goals: to improve supply, quality, accessibility, and efficiency of this nation's blood resources. Several policies evolved from these goals, including efforts toward development of an all-volunteer donor base (available data suggested that blood from paid donors presented increased risk of transmission of hepatitis); regionalization and national resource sharing (data indicated that the blood supply was sometimes inadequate, uneven, and a financial burden); and education (inappropriate use of blood was identified), s The response to these policies has been generally positive. Today, commercial whole blood collection has all but been eliminated in favor of an all-volunteer blood collection system6; the major blood collection organizations in the country have resourcesharing programs in operation. Education of health professionals in the appropriate use of blood and blood components, however, remains a challenge and cause for concem. TRANSFUSION SERVICES AND REGIONAL BLOOD SERVICES
A transfusion service, often hospital based, tests the blood of the intended recipient and is concemed with the transfusion of donor blood and its components. The transfusion service sets standards and supervises the administration of blood in that facility. Those transfusion services that routinely obtain blood from a regional blood service often participate in the governance of the regional program, and share in the combined resources of the region. A regional blood service, such as community blood banks or the American Red Cross, is respon-
sible for providing blood services to a defined geographical area. These services included recruitment of suitable donors, collection of blood, laboratory testing of donor blood samples, preparation of components, and storage and distribution of blood products. Services also include participation in a national resource-sharing program to supplement the regional supply if a shortage should occur. Some regional blood centers may have additional specialized services such as a reference laboratory for assisting in the identification of special antibodies and selection of compatible units for patients having such antibodies; a human leukocyte antigen (HLA) laboratory to achieve the best possible match of platelet donor to platelet recipient; donor apheresis programs for special collections of platelets and white cells; intraoperative autologous transfusion services; a bone marrow donor registry; and small transfusion services. While blood banking agencies differ in philosophies, they are as one regarding sharing the blood resource nationwide. A common objective prevails: those who need blood transfusions shall receive them. 7 REGULATORY AFFAIRS
Blood is defined as both a drug and a biologic by the Food and Drug Administration (FDA). Hospital transfusion services, regional blood centers, and commercial plasmapheresis centers involved in the collection, processing, testing, storage, distdbution and/or transfusion of blood and blood components are required to register annually with the FDA. Furthermore, if the facility intends to ship blood across state lines, a US license is required. 8 The FDA conducts inspections of licensed facilities which are required to report errors, accidents, and fatal complications of blood collection or transfusion. A number of other federal, state, and peer review organizations are also involved in the inspection of blood banks. Some of these organizations are: Health Care Financing Administration (HCFA), Centers for Disease Control (CDC), Occupational Safety and Health Administration (OSHA), College of American Pathologists (CAP), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), American Association of Blood Banks (AABB), and some state health departments. 9 States became more active in the 1970s and again in the 1980s when it
BLOOD COLLECTION TECHNIQUES
was discovered that acquired immunodeficiency syndrome (AIDS) could be transmitted by transfusion. The states have a promulgation of regulations of varying degrees and complexity. VOLUNTARY PROFESSIONAL BLOOD BANKING ORGANIZATIONS
There are three major blood banking organizations in the United States composed of members from transfusion services, regional blood centers, or a combination of both: the American Red Cross, the American Association of Blood Banks, and the Council of Community Blood Centers (Table 1). The American Red Cross (ARC), a notfor-profit organization, and the National Research Council began the first national blood supply operation to support the war effort in 1941. Red Cross chapters initiated a program to establish regional blood centers throughout the United States in 1947. Today, the 56 Red Cross regional blood services operate under one FDA license and under blood services directives issued by the Red Cross national headquarters. Internal audits are performed to ensure that the regional blood services comply with Red Cross policies and directives and federal regulations. The Red Cross collects over 50% of the nation's blood supply and cooperates with the AABB and the Council of Community Blood Centers in the standardization of blood banking activities. The AABB is a not-for-profit organization founded in 1947. The Standards For Blood Banks and Transfusion Services published by this organization are designed to improve the quality and safety of blood transfusion, and are regarded as authoritative by blood bankers and transfusion serTable 1. Major Voluntary Professional Blood Banking Organizations American Red Cross Blood Services National Headquarters 1730 E St, NW Washington, DC 20006 202-737-830rj American Association of Blood Banks 1117 North 19th St, Suite 600 Arlington, VA 22209 703-528-8200 Council of Community Blood Centers 735 15th St NW, Suite 700 Washington, DC 20005 202-393-5725
111
vices worldwide. AABB conducts voluntary inspections for their member institutions and for facilities desiring accreditation. The Council of Community Blood Centers (CCBC) was formed in 1962 by community blood centers. This organization addresses the management aspects of community and regional blood services, and encourages informational exchange and educational efforts. Together, AABB and CCBC fulfill almost 50% of the nation's blood needs. Although the three organizations have differing philosophies, they all cooperate in a strong effort to maintain a safe and available blood supply throughout the nation. 9 VOLUNTEER BLOOD DONATION
Volunteer blood donors ale recruited to donate their blood in a variety of settings, such as community blood drives, on a self-contained "bloodmobile" vehicle, at employer-sponsored blood drives, or hospital-based blood collections. Donors are informed about each step of the donation process (Table 2), about laboratory tests that will be performed on their blood and the notification process if any test results have an implication for their health, and about the physical side effects that might occur during or after the donation. Federal guidelines require that each prospective donor be informed about AIDS, including its signs and symptoms, behaviors that place people at risk for developing AIDS, and transmission of human immunodeficiency virus (HIV) through blood transfusion. Most blood collection agencies provide information that donors are required to read before the health history process is begun. After reading the information, people who recognize that they are at risk for developing AIDS can self-exclude themselves from donation by simply leaving the donation site. Those who feel they cannot leave without drawing attention to themselves can ask the health history interviewer to exclude them from donation. Each donor undergoes a limited health assessment (Table 3), including a health history evaluation, vital sign determination, and hemoglobin estimation, which is documented on a permanent record. Only donors who meet all the established criteria may be accepted for donation, and each is required to sign a statement attesting to the truthfulness of the information provided.
KOTWAS ET AL
112 Table 2. Steps in Donating Blood
Table 3. Quick Check of Criteria for Donor Selection
Registration Information to donors about: Donor and recipient safety Potential adverse reactions Tests to be performed Post-donation instructions Signs and symptoms of AIDS Local telephone number of donation facility Health assessment Vital signs Hemoglobin estimation or hemoglobin-hematocrit determination Review of questions regarding donor and recipient safety Self-exclusion procedure (private location): Donor confidentially indicates whether his or her donation is safe for transfusion Blood pack assembly and distribution Plastic blood container selected by staff for this donation Labeled with unique number Blood donation Final review of donor history responses, check to ensure same unique numbers on bags, tubes, and paperwork Arm inspection (drug abuse, skin disease) Vein selection and aseptic arm prep Phlebotomy and donor observation Blood mixed with anticoagulant Discontinue venipuncture; apply pressure to venipuncture site for 2-3 min Instructions: replace fluids, keep pressure dressing on for 4 h; avoid strenuous exercise, smoking, and alcohol; call us if problem develops Dangle, observe for orthostatic hypotension, venlpuncture site bleeding Post-donation recovery Refreshments and donor observation for 15 rain Followup On adverse reactions Notify donor of any positive test results that would be harmful to their health
On day of donation (55 days required between donations): Age: Between 17 and 66 yr. State law prevails on minimum age. Blood Service physician may accept person over age 66. General appearance: The potential donor must appear healthy. Weight: Minimum 110 lb. Pulse: Usually between 50 and 100. Athletes' may be lower. Temperature: Oral, no higher than 37.5°C. Blood Pressure: Systolic limit, 180; diastolic limit, 100. Further evaluation may be required. Hemoglobin: Current lower limit is 12.5 gldL for females, 13.5 gldL for males. Pregnancy: Ordinarily excluded for 6 weeks after delivery. Travel: International travel to malarial areas, other highrisk countries for AIDS is cause for deferral. Hepatitis: Known history of hepatitis A, B, or C. Positive hepatitis B surface antigen (HbsAg)~ permanent deferral. Blood transfusion during the last 6 months--temporary deferral. History of jaundice requires further evaluation. AIDS: Positive HIV test, AIDS-related complex, Kaposi's sarcoma--permanent deferral. Exposure to AIDS must be evaluated. Medications: The reason for taking the medication will usually determine eligibility. Illness: Diseases of the heart, lungs, liver; a history of abnormal bleeding or cancer is usually cause for deferral. Further evaluation by a physician may be necessary. Immunizations and vaccinations: Killed virus, toxoids, bacterial, or rickettsial OK if symptom free and feeling well. Attenuated viral vaccine, 2-week deferral Rubella, 1-month deferral Rabies, 1-year deferral
Blood collecting agencies are responsible for the permanent identification of the blood donor with the donated blood throughout all steps in the manufacturing process. This process ensures that each unit of blood and each of its components can be traced to its source. Unique labels identify each unit of blood. The donation process itself takes approximately 15 minutes. Prior to venipuncture, the phlebotomist inspects the antecubital areas of both arms, selects a suitable vein, and prepares the venipuncture site with an aseptic solution to prevent contamination of the blood. The phlebotomy is performed with a large-bore (16-gauge) needle, and approximately 450 mL of whole blood is collected into the sterile blood container. On completion of the donation, laboratory testing samples are collected, the phlebotomy is discontinued, and the
All eligibility questions relate to either the protection of the donor or the protection of the recipient.
plastic tubing is sealed to prevent contamination of the collected blood. The needle used in the phlebotomy is removed from the vein and placed in a container for safe biohazard disposal. The blood is placed in a refrigerator or portable cooler to await processing into blood components. Following the donation, the donor is observed for any untoward reaction and given verbal instructions for post-donation care. Refreshments are offered and the donor is asked to remain on site for about 15 minutes, until he or she has adjusted to the blood loss. 1o While the risks of donating blood are generally minor, a small number of people may experience syncope, bruising at the needle site, and nausea. A fewer number may faint and, on rare occasions a donor may experience tetany and convulsion. Four hundred fifty milliliters of blood withdrawn from a 110-lb donor is approximately
BLOOD COLLECTION TECHNIQUES
113
12.7% of the donor's total blood volume (TBV); FDA limit is 15% TBV. Individuals who have been accepted as blood donors are required to perform a confidential unit exclusion procedure. They must review in private the printed material that outlines risk behaviors associated with AIDS, and indicate, either by check mark or selection of a bar-code label, if the donation is or is not safe to be transfused to another person. If the donor indicates that the unit (identified by number only) is not suitable for transfusion or fails to complete the form, the unit of blood must be destroyed. APHERESIS
Apheresis, a Greek word meaning "to remove" or "to take away," is used in blood banking to describe a process whereby whole blood is collected from a donor, the desired components removed, and the remaining portions of blood returned to the donor. There are two main types of
,
Fig 1. Baxter FenwalCS-3000 blood cell separator (Baxter Healthcare Corp, Fenwal Division, Deerfield, IL).
apheresis procedures: plasmapheresis and cytapheresis. Plasmapheresis refers specifically to the removal of plasma. Cytapheresis is a general term used to describe the removal of cellular components, such as platelets (plateletpheresis) and white cells (leukapheresis) (see Fig 1). Although apheresis procedures can be performed manually, the evolution of machinery since the 1950s allows the process to be done automatically. Apheresis methods have the advantage of providing therapeutic doses ofplatelets (3 to 7 × 1011) and granulocytes (1 to 2 × 101°) from one donor; recipients are exposed to fewer donors, potentially reducing the risk of transfusion reactions and transmission of infectious disease. The various components of blood, including red cells, platelets, white cells, and plasma have differing specific gravities. These differentiating densities permit viable separation of blood components by centrifugation. Chemical, radiologic, and immunologic treatments used in cancer therapy
!
114
can compromise a patient's bone marrow and result in pancytopenia. Before platelet separation techniques were perfected, many patients with thrombocytopenia died of hemorrhage. As separation techniques and cancer therapies advanced through the 1960s, control of thrombocytopenic hemorrhage became more effective. Donor Requirements In general, apheresis donors must meet the same selection criteria as whole blood donors. All infectious-disease deferral procedures as described earlier are followed. In addition, plateletpheresis donors are questioned about whether they have ingested medications containing aspirin, as it inhibits platelet aggregation. An evaluation of adverse reactions to previous apheresis or whole blood donations is made to detect possible allergies or fluid retention caused by medications or solutions used in these collection methods. A platelet count is performed to determine eligibility for donation. It is generally contraindicated to accept a donor with a platelet count of < 150,000/l_tL. Additional laboratory monitoring of apheresis donors is necessary for those who donate more frequently than whole blood donors (every 56 days). Frequent donors are required to have a serum protein level above 6.0 g/dL and IgM and IgG levels within normal limits. White blood cell counts, including differential, are also monitored. Total red cell loss (combined whole blood, apheresis donations, and laboratory samples) is limited to the equivalent in maximum whole blood donations per year. Plasma loss is limited to the World Health Organization standard of 15 L/yr. Donations may occur up to twice per week, but no more frequently than every 48 hours; plateletpheresis is currently limited to 24 times per year. ~ Most organizations limit the number of leukapheresis donations due to the theoretical risk of lymphocyte depletion. Apheresis products may be collected to provide platelet concentrates for hospital inventories, or donors may be specifically selected on the basis of their human leukocyte antigen (HLA) type. Informed consent is obtained for all apheresis procedures; it includes a description of the procedure and the risks involved, acknowledgment that the long-term effects of the loss of lymphocytes is unknown, and a statement about donors' right to ask questions or withdraw from the procedure at any time.
KOP,NAS ET AL
Instrumentation The focus of blood banking is gradually shifting from manual separation of components obtained from whole blood to specific donors and blood obtained by automated blood collection methods. The first apheresis instrument, developed in the 1950s, enabled the separation of plasma from various formed elements of blood. Significant advances in cytapheresis over the last 20 years have led to computerized instruments capable of more precise packing of cells and higher-yield products. Current automated instruments use specially designed disposable plastic harness sets with one or two large-bore, 16-gauge needles for one-arm or two-arm procedures. An anticoagulant solution is added automatically at a specific ratio to the volume of blood collected to keep the blood from clotting during the process. Approximately 5,000 mL of donor blood flows through the disposable software in about 1 to 1I/2 hours (needle in to needle out). To obtain different components the donor's blood enters a chamber, bowl, or channel. The centrifugal force separates the different components, and strategically placed tubes remove the desired component, which flows into a plastic product container. Depending on the instrument used, approximately 250 mL to 450 mL of donor blood is extracorporeal at any given time. Because the therapeutic effects of granulocyte therapy are not well defined, the collection of granulocytes (leukapheresis) is not routinely prescribed, t2 Potential Donor Reactions In addition to potential adverse reactions associated with whole blood donations, such as syncope and nausea, apheresis donors may experience reactions as a result of the cooling of the processed blood or infused solutions and/or medications. Most reactions are mild and can be alleviated if the procedure is temporarily stopped. Apheresis donors are exposed to the same risk of citrate toxicity as blood recipients who have multiple and rapid transfusions. The reinfusion of citrated blood accompanying transient hypocalcemia may cause various paresthesias. Often paresthesias are described as circumoral or facial numbness or tingling, coolness of the throat, or a sensation of the donor chair vibrating. The donor may feel cold and begin to shiver. These symptoms are transient and can be reduced by slowing the reinfusion of blood
BLOOD COLLECTION TECHNIQUES
to the donor and allowing the liver to metabolize the citrate. Visual checks of the harness for flow restrictions and/or damage to the tubing during setup and throughout the procedure are essential to prevent air from entering the harness. 13 Standard operating procedures for both life-threatening and non-life-threatening situations are required. Because of the additional potential risks involved in apheresis procedures, the availability of medical assistance is warranted. AUTOTRANSFUSION AND CELL SAVING
The fear of transfusion-transmitted infections, particularly AIDS and hepatitis, has led to a renewed interest in the use of a person's own blood. Autologous blood has long been known to provide the safest and most compatible transfusion possible, but only recently has become a widely accepted transfusion alternative.14 Autologous blood programs and services, which collect and process one's own blood preoperatively, intraoperatively, and/or postoperatively, have grown in number and scope throughout the country.
Preoperative Autologous Donation Donating blood in advance of scheduled surgery for one's own use during a surgical procedure is the most common form of autologous donation. The number of units to be collected depends on the type of surgical procedure scheduled and the potential blood loss. Many patients begin the process up to 6 weeks before surgery and are able to donate 5 units of blood to be stored in the liquid state. Blood must be stored frozen if collected too far in advance of the date needed. Medical eligibility criteria for autologous donors are less stringent than the requirements for volunteer blood donors because receiving one's own blood adds no new risk of blood-transmitted disease. A person with a history of malignancy is a prime example of someone who may be precluded from donating blood for someone else but not for himself. Autologous donors are not held to the same strict weight or age requirements, which allows children and underweight donors to donate blood for themselves. Donors who might be considered high risk, such as those with a history of coronary artery disease, or pregnant women, are also considered candidates for autologous donation, depending on physical evaluation. In addition, autologous donors are permitted to have their blood
115
collected at shorter intervals than individuals donating for others.
Normovolemic Hemodihaion Acute normovolemic hemodilution provides patients another autologous option, especially if the patient is unable to donate blood preoperatively (eg, before bypass surgery), or if there is not sufficient time to predonate. Performed in the operating room immediately after the induction of anesthesia, hemodilution involves the withdrawal of I or 2 units of the patient's blood. A crystalloid or colloid solution is simultaneously infused during the phlebotomy to maintain the patient's circulating volume. The fresh, whole blood is generally returned to the patient in the operating room after bleeding is brought under control.
hztraoperative Autologous Transfusion Intraoperative autologous transfusion (IAT), also referred to as " c e l l salvage" or "cell saving," offers still another autologous option. IAT is a procedure whereby blood normally lost during the course of surgery is saved and subsequently returned to the patient. IAT devices range from sterile hand-held canisters that provide gross filtration of blood and can simply be inverted for reinfusion, to more technologically sophisticated devices capable of collecting, separating, and washing the blood. These latter autotransfusion machines have been used in cardiac and vascular surgery for more than 15 years, and more recently have gained widespread acceptance in transplantation and major orthopedic procedures. Suspicion of a malignant lesion is generally considered a contraindication for IAT because of the potential collection of malignant cells and subsequent intravenous transfusion, although this is still somewhat controversial. 15
Postoperative Autologous Collection Blood loss following cardiac surgery and certain orthopedic procedures, such as total knee replacement, can be significant. Collection devices are available to salvage blood from the pleural space or surgical wound for subsequent reinfusion. The sterile collection canisters are connected to the drains in the operating room. Depending on the surgeon's preference, the blood may be washed before reinfusion or reinfused directly from the collection device.
116
KOTWAS ET AL SUMMARY
To date, there is no substitute for human blood. It is the only source material for the manufacture of cellular components and fractionated plasma products. Whole blood donation has transversed many
risk barriers experienced in early collections and has become a relatively minor and uncomplicated procedure. Blood collection techniques have made significant advances, particularly in recent years, making blood components an essential part of specific cancer treatments.
REFERENCES
1. KorkoszA: The Blood Bank. Davis NursingSurvey, vol 6. Philadelphia,PA, Davis, 1942, p 371 2. GreenwaltTJ: An autobiographicalperspective of blood banking, 1946 to 1988. TransfusionMed 29:250, 1989 3. Winthrop MM: Blood Pure and Eloquent. New York, NY, McGraw-Hill, 1980, p 691 4. KleinHG: Transfusionmedicine:The evolutionof a new discipline. JAMA 258:2108-2109, 1987 5. SchmidtPJ: Nationalblood policy, 1977: A study in the politics of health, in Brown EB (ed): Progress in Hematology, vol 10. Philadelphia,PA, Grune & Stratton, 1977, p 169 6. US Congress, Office of TechnologyAssessment: Blood Policy and Technology. Washington,DC, OTA-H-260,publication 85-601151, 1985, pp 25-108 7. Food and Drug Administration:Title 21, Code of Federal Regulations. Washington,DC, Departmentof Health and Human Services, parts 600 and 601, 1989 8. Pittiglio DH: Modern Blood Banking and Transfusion Practices. Philadelphia,PA, Davis, 1983, pp 284-286
9. RutmanRC, Miller WV: TransfusionTherapy Principles and Procedures (ed 2). Rockville, MD, Aspen, 1985 10. American Red Cross Blood Services Directives. 5.17, Blood Collection Procedures; 5.29, Donor Processing and Management. Washington, DC, American Red Cross, 1981 and 1988 11. Food and Drug Administration,Division of Blood and Blood Products: RevisedGuidelinesfor the Collectionof Platelets, Pheresis Preparedby AutomatedMethods. Bethesda, MD, FDA, 1988 12. Snyder EL, KennedyMS, BlumbergN: Blood transfusion therapy: A physician's handbook (ed 2). Arlington, VA, American Associationof Blood Banks, 1987 13. Kotwas L: Pheresis Donor Reactions and Complications, Prevention,Recognition,and Management:Fundamentals of a Phereis Program. Washington,DC, AABB, 1979, pp 63-76 14. PopovskyMA, Devine PA, Taswell HF: Intraoperative autologous transfusion.Mayo Clin Proc 60:125-134, 1985 15. Glover JL, Broadie TA: Intraoperativeautotransfusion. World J Surg 11:60-64, 1987