MEDICAL SERVICES MANUAL
American Red Cross
Blood Services
Southwest Region
MEDICAL SERVICES MANUAL
American Red Cross Blood Services
Southwest Region
TABLE OF CONTENTS
INTRODUCTION:
Southwest Region Blood Services .................................................................................................... i
Telephone Directory...................................................................................................................... ii
Donor Centers ..........................................................................................................................iii-iv
Medical/Technical Coverage ............................................................................................................ v
Regulatory Information:
CLIA Identification Numbers....................................................................................................... vi
Food and Drug Administration.................................................................................................... vii
BLOOD PRODUCTS:
Ordering ........................................................................................................................................... 1
Circular of Information .................................................................................................................... 1
Blood and Blood Components Available Through Hospital Services .............................................. 2
Whole Blood ................................................................................................................................. 3-4
Red Blood Cells ............................................................................................................................ 5-6
Red Blood Cells, Leukocytes Reduced (by Prestorage Filtration) ................................................. 7-8
Red Blood Cells Deglycerolized ................................................................................................. 9-10
Platelets, Random Donor Platelets, or Platelet Concentrates ..................................................... 11-12
Platelets or Random Donor Platelets, Leukocytes Reduced ...................................................... 13-14
Platelets, Pheresis or Single Donor Platelets (SDPs)
(including Leukocytes Reduced, HLA-Matched and Crossmatched SDPs) ............................ 15-17
Granulocytes (Buffy Coat and Pheresis) ................................................................................... 18-19
Fresh Frozen Plasma ................................................................................................................. 20-22
Fresh Frozen Plasma, Jumbo ..................................................................................................... 23-24
Plasma Frozen Within 24 Hours .................................................................................................... 25
Plasma, Cryoprecipitate Reduced ................................................................................................... 26
Cryoprecipitate AHF ................................................................................................................. 27-28
Blood Products for Neonatal/Pediatric Patients.............................................................................. 29
Irradiated Blood Components.................................................................................................... 30-31
Plasma Derivatives ........................................................................................................................ 32
Rh Immune Globulin.............................................................................................................. 33-34
Varicella Zoster Immune Globulin (VZIG) ................................................................................. 35
HOSPITAL SERVICES:
Ordering Blood and Blood Products ............................................................................................. 1-3
Return and Transfer Policies ......................................................................................................... 4-5
Packaging Blood Products for Return/Transfer ................................................................................ 6
Delivery Schedules ........................................................................................................................... 7
Response Time ................................................................................................................................. 8
Emergency and Exceptional Releases of Blood Products ................................................................ 9
Inventory Information .................................................................................................................... 10
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PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
TABLE OF CONTENTS (continued)
REFERENCE LABORATORY:
Hours of Operation ........................................................................................................................... 1
Specimen Referral Guidelines ....................................................................................................... 1-2
Specimen Collection Requirements.................................................................................................. 3
Transportation .................................................................................................................................. 3
Reporting Results ............................................................................................................................. 3
Contract Transfusion Service ........................................................................................................... 4
Component Selection ....................................................................................................................... 4
Rare Donor Blood ......................................................................................................................... 4-5
TESTING LABORATORIES:
National Testing Laboratory............................................................................................................. 1
Confirmatory Laboratory.................................................................................................................. 1
National Genome Testing Laboratory ........................................................................................... 1-2
QUALITY CONTROL:
Quality Control of Blood Components ............................................................................................. 1
Quality Control of Shipping Containers ........................................................................................... 2
Recalls/Market Withdrawals ............................................................................................................ 2
POST-TRANSFUSION RECIPIENT MANAGEMENT:
Possible Recipient Transfusion-Transmitted Infection (PRTTI) ................................................... 1-2
Possible Transfusion Reaction Case Report .................................................................................. 2-3
Lookback Programs ....................................................................................................................... 3-4
QUALITY ASSURANCE:
Quality Assurance Structure ............................................................................................................. 1
Quality Assurance Department Responsibilities ........................................................................... 1-2
Reports of Record Reviews, Audits, and Verifications .................................................................... 2
Regulatory Compliance and Quality Audits (RCQA) ................................................................... 2-3
Other External Inspections ............................................................................................................... 3
Proficiency Testing........................................................................................................................ 3-4
APHERESIS SERVICES:
Definition ......................................................................................................................................... 1
General Information ...................................................................................................................... 1-2
Specific Products .............................................................................................................................. 2
Guidelines for Ordering and Using Apheresis Products ................................................................ 2-6
Therapeutic Apheresis Services .................................................................................................... 6-7
SPECIAL COLLECTIONS:
Autologous Donations (“Preoperative”) ....................................................................................... 1-3
Directed Donations........................................................................................................................ 4-6
Therapeutic Phlebotomy Services ................................................................................................. 7-8
EDUCATIONAL SERVICES:
Educational Services ........................................................................................................................ 1
BILLING:
Billing, Processing Fee Schedules and Product Codes ..................................................................... 1
ATTACHMENTS
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PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
INTRODUCTION
Page i
SOUTHWEST REGION
The American Red Cross Blood Services, Southwest Region, is a not-for-profit organization providing blood,
blood products and transfusion services to approximately 90 hospitals in over 70 Oklahoma and Texas counties,
along with many home health and outpatient transfusion facilities. It is one of over 35 regions (“blood centers”)
within the American Red Cross Blood Services, a branch of the National American Red Cross.
The American Red Cross Blood Services was established in 1949 to provide hospitals and clinics with a wide
range of blood banking services. These services meet standards set by the National American Red Cross, the Food
and Drug Administration (FDA) and the American Association of Blood Banks (AABB). It constantly strives to
improve and refine its services, as well as to efficiently respond to patient needs. Safety, purity and potency of
each blood product are assured by implementation of new tests and extensive quality assurance processes.
The donor recruitment philosophy of the American Red Cross is based on community responsibility: healthy
people give so that blood is ready for all who need it: children, the elderly, the chronically ill, and trauma victims.
There is no charge for voluntarily donated blood. The only fee passed on to hospitals and then to patients is the
"processing fee." This processing fee covers costs incurred by the Red Cross for recruiting, collecting, testing,
processing, storing and distributing blood and blood products.
The Red Cross does not require blood replacement or pre-placement for patients who use blood. However, when
friends and family members wish to make donations to replenish the community's blood supply, their donations
are most welcome by the Red Cross.
The purpose of Donor Resources is to encourage healthy, eligible individuals to donate blood at various collection
sites throughout the Southwest Region. This is accomplished through a complex system of organizing and
scheduling. It includes educational, motivational, and marketing efforts, coordinated by Donor Resources staff in
the territory in which the Southwest Region operates. Telephone recruiters are responsible for recruiting donors to
balance stock inventory levels, fill special orders, and encourage repeat donations.
Bloodmobile sponsors (hospitals, industries, communities, high schools, colleges, etc.) provide the sites for blood
drives, recruit and schedule donors, and assist in overseeing the entire operation on the day of collection.
Thereafter, evaluation, recognition, and planning for future bloodmobiles take place. By efficiently utilizing
volunteers, collection staff and equipment, a collection goal of over 160,000 units per year is met.
If interested in sponsoring a bloodmobile, or for questions about giving blood or receiving blood and blood
products, please call 1-800-GiveLife.
The staff of the American Red Cross Blood Services is eager to assist you with any problems or questions you
have. Always feel free to contact us.
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PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
INTRODUCTION
Page ii
TELEPHONE DIRECTORY
Southwest Region Headquarters......................................................................................... (972) 241-4483
Administration/CEO ................................................................................................. (469) 341-1002
Medical Director ....................................................................................................... (918) 831-1171
Regional Inventory .................................................................................................... (469) 341-1027
Regulatory Affairs ..................................................................................................... (918) 831-1184
Tulsa Location ...................................................................................................................... (918) 831-1100
Donor Resources ....................................................................................................... (918) 831-1235
Donor Services
Autologous & Directed Collections Scheduling ............................................... (918) 831-1219
Toll Free............................................................................................................ (800) 877-1624
Fax .................................................................................................................... (918) 831-1646
Apheresis/Hemapheresis ................................................................................... (918) 831-1156
Hospital Services ....................................................................................................... (918) 831-1115
Reference Laboratory ................................................................................................ (918) 831-1131
Recalls and Market Withdrawals............................................................................... (888) 584-7970
Reporting Possible Transfusion Transmitted Infections,
Possible Transfusion Reactions, and Lookback Programs ................................ (866) 210-5495
Bryan/College Station Location .......................................................................................... (979) 268-4755
Dallas Location ..................................................................................................................... (972) 241-4483
Administration/CEO .................................................................................................. (469)341-1002
Hospital Services ......................................................................... (888) 252-5663 or (972) 241-4039
Harlingen Location .............................................................................................................. (956) 428-4543
Hospital Services ......................................................................... (888) 452-5663 or (956) 428-8267
Longview Location ............................................................................................................... (903) 753-2091
Waco Location ...................................................................................................................... (254) 776-8754
Hospital Services ......................................................................... (800) 460-8503 or (254) 776-8510
Wichita Falls Location ......................................................................................................... (940) 322-8686
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
INTRODUCTION
Page v
DONOR CENTERS
OKLAHOMA
Tulsa
Southside Donor Center
th
10151 East 11 Street
Tulsa, OK 74128
7717 South Memorial
Tulsa, OK 74133
PHONE:
FAX:
PHONE:
FAX:
(918) 831-1151
(918) 499-3967
(918) 250-8818
(918) 461-9846
TEXAS
Bryan/College Station
Longview
701 University Drive East, Ste#103
College Station, Texas 77840
1604 Highway 31
Longview, TX 75604
PHONE:
FAX:
PHONE:
FAX:
(979) 268-4755
(979) 268-4063
(903) 753-2091
(903) 753-7143
Dallas
Waco
One Medical Parkway, Suite 215
Farmers Branch, TX 75234
4224 Cobbs Drive
Waco, TX 76710
PHONE:
FAX:
PHONE:
FAX:
(214) 943-2863
(214) 943-5638
(254) 776-8754
(254) 776-9089
Harlingen
Wichita Falls
612 Ed Carey
Harlingen, TX 78550
1809 5th Street
Wichita Falls, TX 76301
PHONE:
FAX:
PHONE:
FAX
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PD:02/05/16, Administration
(956) 428-4543
(956)428-7057
(940) 322-8686
(940) 322-1791
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
INTRODUCTION
Page v
MEDICAL/TECHNICAL COVERAGE
During the work week, Monday - Friday, 0830 to 1700, calls can be directed to the appropriate department as
listed on page ii. For all other times, calls should be directed to Hospital Services at the numbers listed below.
Hospital Services will refer your message to the appropriate on-call personnel.
OKLAHOMA
Tulsa Location Hospital Services: ........................................................... 1-800-722-5971 or (918) 831-1115
TEXAS
Dallas Location Hospital Services: .......................................................... 1-888-252-5663 or (972) 241-4039
Harlingen Location Hospital Services: .................................................... 1-888-452-5663 or (956) 428-8267
Waco Location Hospital Services:........................................................... 1-800-460-8503 or (254) 776-8510
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
INTRODUCTION
Page vi
CLIA IDENTIFICATION NUMBERS
TULSA Location: 37D0474123
DALLAS Location: 45D0659989
These CLIA identification numbers are provided for information purposes only during CLIA inspections.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
INTRODUCTION
Page vii
FOOD AND DRUG ADMINISTRATION
All Blood Services in the American Red Cross system operate under a single FDA license, #190, for general blood
collection, processing and distribution. A few specific products and procedures require region- or locationspecific licensure, such as jumbo fresh frozen plasma or irradiation performed by the Red Cross facility.
Occasionally, a blood product is distributed in which the FDA license number on the product's label has been
obliterated. This product still meets all requirements for safety and purity, but deviates from some specific federal
definition or standard, usually in regards to the type of product for which we do not have licensure. For example,
occasional products, especially apheresis platelets, may not meet minimum product requirements (such as platelet
count) but still meet all other standards for safety and purity. These units are distributed as unlicensed products
and a reduced processing fee is charged. Before shipping any unlicensed product, Red Cross HS staff asks the
receiving hospital if it is willing to accept such a product. For platelet products that do not meet the minimum
required platelet count, the receiving hospital is advised to “tag” such products indicating the “below standard”
platelet count, and if possible, issue these products for infusion to pediatric patients or adult patients weighing less
than the average weight of 70 kg. The platelet count of each unit is provided.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
BLOOD PRODUCTS
Page 1
ORDERING
The following sections describe each blood product available through the Hospital Services Department. A list of
these products is on the next page. Orders for these products should be directed to the following phone numbers:
IN OKLAHOMA:
Tulsa Service Area:
(918) 831-1115
Toll-free: 1-800-722-5971
IN TEXAS:
Dallas Service Area:
Waco Service Area:
(972) 241-4039
Toll Free : 1-888-252-5663
(254) 776-8510
Toll Free: 1-800-460-8503
Harlingen Service Area:
(956) 428-8267
Toll Free: 1-888-452-5663
CIRCULAR OF INFORMATION
When a new version of the Circular of Information (COI) is published, copies are routinely distributed to each
hospital transfusion service in the Southwest Region. Additional copies may be obtained by calling the Hospital
Services Department that services your hospital. All products and their use are described in the COI. For your
convenience, it can be placed in this manual upon receipt, so you will always have a current copy.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 2
BLOOD and BLOOD COMPONENTS
Available Through HOSPITAL SERVICES
Whole Blood1
Red Blood Cells1
Red Blood Cells, Leukocytes Reduced (by Prestorage Filtration)
Red Blood Cells, Frozen and Deglycerolyzed2
Red Blood Cells, Crossmatched2
Red Blood Cells, Antigen-Matched or Antigen-Specific2
Platelets/Random Donor Platelets/Platelet Concentrates
Platelets/Random Donor Platelets, Leukocytes Reduced (by Prestorage Filtration )1
Platelets, Pheresis or Single Donor Platelets—Leukocytes Reduced
Platelets, Pheresis—HLA-matched
Platelets, Crossmatched2
Granulocytes3
Fresh Frozen Plasma
Fresh Frozen Plasma, Jumbo
Plasma Frozen Within 24-Hours
Plasma, Cryoprecipitate Reduced
Cryoprecipitated AHF
Blood Products for Neonatal/Pediatric Patients4
Irradiated Blood Components5
LATEX-FREE Blood Components are available by special order; please call the Tulsa Location Reference
Laboratory to order.
PLASMA DERIVATIVES: The Southwest Region no longer stocks any plasma derivatives.
Your hospital’s pharmacy or purchasing group/vendor would be the likely source for these products.
1Requires
an advance order, unless arrangements are made with the ARC to establish a standing order.
Requires specific order called in to Reference Lab (see chapter “Reference Laboratory”).
3Requires an advance order with a turn-around-time of at least 36 hours. Product also requires release via
“Emergency Release” protocol, i.e., approvals are required from both the requesting physician (or the hospital
Transfusion Service Medical Director as designee) and the ARC Medical Director in order to release product
prior to completion of standard tests. Since the product has only a 24-hour shelf life, ‘emergency release’
allows shipment to the hospital with sufficient time to use the product before its expiration.
4 Specifications for type of unit desired is to be arranged with ARCBS-SWR as a “standing” order or on a
case-by-case situation as the need arises. For the latter, a delay of at least 36 hours may occur in order to
produce the desired product(s).
5 Certain products require irradiation and the customary fee will be automatically assessed. Otherwise, order
as needed.
2
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 3
WHOLE BLOOD (WB)
Description
Composed of all cellular and plasma constituents as found in blood circulating in the body. Collected from
allogeneic, autologous, or directed donors in a single plastic blood bag that contains an anticoagulant and
preservative solution.
NOTE:
Whole Blood is available on a limited basis as a special order only or as a prearranged standing
order (for stock inventory). Special orders must be approved by the ARC Medical Director, and
received at least 36 hours in advance. These units will be NON-leukoreduced unless specifically
ordered as leukoreduced whole blood.
Anticoagulant/
Preservative
Approximate
Volume
HCT
Shelf Life & Storage
When stored @ 1-6 ºC
CPD
500ml
35 – 40%
21 days
CPDA-1
500ml
35 – 40%
35 days
Actions
1. Increases oxygen-carrying capacity
2. Increases total blood volume
Indications
1. Acute, massive blood loss (25% or more of total blood volume)
2. Exchange transfusion of the neonate
3. Hypoxia with hypovolemia
Contraindications
1. Do not use when anemia can be treated with packed red blood cell components or specific medications.
2. Do not use when blood volume can be safely and adequately replaced by volume expanders such as colloids
and crystalloids.
3. Do not use for correction of coagulation factor deficiencies.
Potential Adverse Effects
1.
2.
3.
4.
5.
6.
7.
Hemolytic transfusion reactions—acute or delayed
Allergic and anaphylactoid/anaphylactic reactions
Febrile nonhemolytic reactions
Alloimmunization
Transfusion-transmissible infectious diseases (e.g., HIV/AIDS, HCV, HBV, WNV)
Transfusion-associated graft-versus-host disease (TA-GVHD)
Bacterial contamination
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 4
8.
9.
10.
11.
12.
Transfusion-related acute lung injury (TRALI)
Circulatory overload
Hypothermia (with massive transfusions)
Dilution of coagulation proteins and platelets (with massive transfusions)
Metabolic complications including citrate toxicity (with massive transfusions) and iron overload (from
long-term, repeated transfusions).
Dosage
Depends on clinical condition; 1 unit increases the hemoglobin and the hematocrit by approximately 1 g/dL
and 3%, respectively, in the average adult patient (weighing 70 kg).
Rate of Infusion
As fast as can be tolerated; total transfusion time should not exceed four hours per unit. Initiate transfusion
at a slow rate and monitor patient closely during start of transfusion, for about the first 15 minutes.
Administration
1. Must be ABO identical and Rh compatible (i.e., “group-specific” or “group identical”).
2. Crossmatching is required if the recipient has clinically significant, unexpected red cell antibodies either
currently detectable or by history. Deviations require approval by the hospital transfusion service Medical
Director or designee.
3. Follow an acceptable method to identify patient and confirm that the unit has been crossmatched for that
patient.
4. Use a standard blood administration set: Y-type tubing with a standard blood filter, with pore size of 150
to 280 microns.
5. Except for normal saline, do not add solutions or medications to the blood, or through the same tubing
during the infusion of blood, unless such solution or medication has been approved for this use by the
FDA or has been shown and documented to be safe and to not adversely affect the blood component
(AABB Standards, 23rd Edition).
6. If clinically indicated, blood may be warmed using an FDA-approved blood-warming device equipped
with a temperature sensing device and a warning system to detect malfunctions, prevent hemolysis or
other damage to red blood cells (AABB Standards, 23rd Edition).
7. A microaggregate filter may be used but is not indicated and may add unnecessary costs (see footnote).
Footnote:
Microaggregate filters with a pore size of 40 microns were initially used to filter out small aggregates
composed of platelets, leukocytes, and fibrin strands that developed during storage. It was believed that these
microaggregates contributed or even caused the development of adult respiratory distress syndrome (ARDS)
that often occurred during massive transfusions. However, as a better understanding of ARDS developed,
microaggregates were found not to be the primary cause. This finding, in addition to the increased or even
exclusive use of pre-storage leukoreduced blood components, is eliminating the need for the use of
microaggregate filters. These filters do not achieve the degree of leukocyte reduction that pre-storage
leukocyte reduction achieves and certainly not levels that consistently provide the clinically desired effects.
(McCullough, 1998)
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 5
RED BLOOD CELLS (RBC)
Description
The unit of red blood cells (RBCs) that remain after removing almost all plasma from a unit of whole blood
which has undergone centrifugation. These units are NOT leukocyte-reduced, and sometimes are referred to
as “vanilla” units. (Almost all blood components are routinely leukocyte-reduced.)
Depending on the anticoagulant/preservative solution used, the following parameters will vary. Those to
which an additive solution (such as AS-1, AS-3, or Optisol®) has been added will have a volume and
viscosity much more like a unit of whole blood.
Anticoagulant
Approximate
Volume
HCT
Shelf-Life & Storage
Stored at 1-6ºC
CPD
CPDA-1
AS-1/-3, or Optisol®
300ml
300ml
300-400 ml
65-75%
65-75%
50-60%
21 Days
35 Days
42 Days
Actions
1. Increases oxygen carrying capacity
2. Increases red blood cell mass
Indications
1. Improve Hgb/Hct to increase oxygen-carrying capacity, such as in symptomatic anemia.
2. Replace clinically significant acute blood loss as in trauma, or with open heart surgery, etc.
3. May be used for exchange transfusion.
Advantages over Whole Blood
1. Hemoglobin replacement is roughly two times as great per unit volume.
2. Decreased chance of circulatory overload.
3. Decreased amounts of ABO group-directed donor antibody due to plasma removal, and therefore able to
use “ABO-compatible” units.
4. Specific and selective replacement of only the oxygen-carrying component (i.e., RBCs).
5. May be prestorage leukoreduced by filtration or by bedside filtration. The latter method is not as reliable
and is not recommended since more variables influence this filtration process, with fewer means of
controlling such variables. See section “Red Blood Cells, Leukocytes Reduced (by Prestorage
Filtration).”
Contraindications
1. Do not use when anemia can be corrected with specific medications or pharmaceuticals, such as
erythropoietin.
2. Do not use to correct coagulation deficiencies.
3. Do not use simply to increase total blood volume or to increase H/H to some formulaic level.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 6
Potential Adverse Effects
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
Hemolytic transfusion reactions
Allergic and anaphylactoid/anaphylactic reactions
Febrile nonhemolytic reactions
Alloimmunization
Transfusion-transmissible diseases (e.g., HIV/AIDS, HCV, HBV, WNV)
Transfusion-associated graft-versus-host disease (TA-GVHD)
Bacterial contamination
Transfusion-related acute lung injury (TRALI)
Circulatory overload
Hypothermia (with massive transfusions)
Dilution of coagulation proteins and platelets (with massive transfusions)
Metabolic complications including citrate toxicity (with massive transfusions) and iron overload (with
long-term, repeated transfusion support therapy).
Dosage
1. For average adult (70kg), 1 unit should  hemoglobin and hematocrit by ~ 1 g/dL and 3%, respectively.
2. In pediatric patients, 8-10 mL/kg body weight should  hemoglobin by about 2 g/dL and the hematocrit
by about 6%.
Rate of Infusion
Depends on clinical condition, but total transfusion time should not exceed four hours per unit. Initiate
transfusion at a slow rate and monitor patient closely during start of transfusion, for about the first 15 minutes.
Administration
1. Recipient’s plasma must be ABO and Rh compatible to the donor’s red cells; units do not have to be
ABO-specific. However, the hospital should have a written policy stating the circumstances that warrant
the use of incompatible red cells (e.g., Rh positive red cells given to an Rh negative patient), or at least a
statement of the person (by title) who is able to approve such use.
2. Crossmatching is required if the recipient has clinically significant, unexpected red cell antibodies either
currently detectable or by history. Deviations require approval by the hospital transfusion service Medical
Director or designee.
3. Except for normal saline, do not add solutions or medications to the blood, or through the same tubing during
the infusion of blood, unless such solution or medication has been approved for this use by the FDA or has
been shown and documented to be safe and to not adversely affect the blood component (AABB Standards,
23rd Edition).
4. Addition of 0.9% NaCl is usually not needed for PRBC units that contain an additive solution, such as
AS-1/-3, or Optisol®.
5. Use a standard “blood administration” set: Y-type tubing with a standard 150 to 280 micron filter.
6. If clinically indicated, blood may be warmed using an FDA-approved blood warming device, equipped
with a temperature sensor and a warning system that detects malfunctions and prevents hemolysis or other
damage to red cells (AABB Standards, 23rd Edition).
7. A 19-gauge or larger needle is recommended although one as small as 23-gauge can be used. If using
small gauge needles, infusion done under pressure might result in hemolysis. The infusion device’s
directions for use should be checked to ensure that it can be used for transfusing blood products
8. A microaggregate filter may be used but is not indicated and may add unnecessary costs (see footnote in
Whole Blood section).
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 7
RED BLOOD CELLS
LEUKOCYTES REDUCED
(by Prestorage Filtration)
Description
A closed system filtration is performed during processing to yield a unit of leukoreduced red blood cells
(LRBCs). The filtration step generally occurs within 24 hours of collection, but can be performed up to day 5
(after collection). Such filtered units can be labeled “prestorage leukoreduced”, as long as quality control
checks show that fewer than 5 x 106 white blood cells (WBCs) remain and at least 85% of the original mass of
red blood cells (RBCs).
Though not measured, studies show that units, which have been leukoreduced soon after collection, that is,
“pre-storage,” have a reduced accumulation of cytokines during storage. This reduction in cytokines is one of
the reasons cited for some of the attributes (and benefits) of using leukoreduced blood components. Units that
are leukoreduced “prestorage” are considered to be more effectively leukoreduced as opposed to those that are
leukoreduced by filtration at the bedside.
NOTE: Some time in the near future, LRBC that have been collected by apheresis collection methods will
also be available. The vast majority of the following information on LRBC will also apply to
apheresis-collected LRBC.
Anticoagulant/
Preservative
Approximate
Volume
HCT
Leukocyte Count
AS-1/-3 or
Optisol®
300-400ml
50-60%
< 5 x 106
Shelf-Life & Storage
When stored @ 1-6ºC
42 days
Actions
Same as for packed RBCs
Indications
Same as for RBCs with the following additions/conditions:
1. Prevent repeated episodes of non-hemolytic febrile transfusion reactions.
2. Prevent alloimmunization to white cell antigens; prevent or delay refractoriness to platelet transfusions.
3. Reduce likelihood for cases of TRALI in which the recipient has the antibodies.*
4. Reduce the risk of CMV-transmission (though some controversy still exists as some physicians still accept
only serologically negative CMV-tested units as being “CMV safe”).*
5. Reduce transfusion-induced immunosuppression, and its possible consequences, such as post-operative
infection.*
6. Reduce transmission of bacteria, HTLV, and Chagas disease.*
7. Reduce reperfusion injury.*
8. Reduce viral reactivation (e.g., CMV, HIV).*
* Potential benefits, still controversial, and not yet universally accepted or unequivocally proven—a selected
bibliography:
Blumberg N, Heal J: Blood transfusion immunomodulation—the silent epidemic. Arch Path Lab Med; Feb. 1998.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 8
Bowden RA, Slichter SJ, Sawyer SM, Weisdorf D., et al: A comparison of filtered leukocyte-reduced and cytomegalovirus
(CMV) seronegative blood products for the prevention of transfusion-associated CMV infection after marrow transplant. Blood
1995;86:3598-3603. (landmark study)
Jensen LS, Andersen AJ, Christiansen PM, et al: Postoperative infection and natural killer cell function following blood
transfusion in patients undergoing elective colorectal surgery. Br J Surg 1992;79:513-516.
Tartter PI: The association of perioperative blood transfusion with colorectal cancer recurrence. Ann Surg 1992;216:633-638.
Van de Watering LM, et al: Beneficial effects of leukocyte depletion of transfused blood on postoperative complications in
patients undergoing cardiac surgery: a randomized clinical trial. Circulation 1998;97:562-568.
Contraindications
Same as for RBCs
Potential Adverse Effects
Same as for Red Blood Cells but with the following differences:
1.
Reduced incidence of febrile nonhemolytic reactions.
2.
Reduced incidence of allergic, anaphylactoid reactions.
3.
Reduced incidence of alloimmunization to HLA antigens.
4.
Reduced incidence of certain transfusion-transmissible infections such as CMV.
5.
Reduced incidence of bacterial contamination.
NOTE: The risk for TA-GVHD still exists with “leukoreduced” blood. Therefore, if recipient is at risk for
TA-GVHD, irradiation of cellular blood products is still required, regardless of whether units are
leukoreduced or not, as viable leukocytes are still present. At this time, the degree of leukoreduction
attainable has not been proven to be effective in preventing TA-GVHD.
Dosage
Depends on clinical condition; same as for RBCs.
Rate of Infusion
Total time of infusion should not exceed a total of four hours per unit, as for regular RBCs.
Administration
Same as for regular RBCs.
NOTE: Do NOT use a leukocyte-reducing filter at the bedside, or a microaggregate filter, when
transfusing prestorage leukoreduced blood components.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 9
RED BLOOD CELLS, FROZEN AND DEGLYCEROLYZED
Description
A unit of red blood cells, previously frozen, is thawed and processed to remove (by washing) the cryopreservative,
i.e., "deglycerolyzation." The deglycerolyzation process must ensure that mean red cell recovery is at least 80% of
the original red cell volume, cryoprotective agents are adequately removed, and final product has minimal free
hemoglobin. Therefore, a thawed unit contains normal saline instead of plasma, has a hematocrit of 70-80%, and
a red cell mass less than that in the original unit.
Though leukocytes are reduced to <10% of that in a regular RBC unit, the WBC generally does not meet the
AABB/FDA cut-off of <5 x 106, and therefore these products cannot be labeled “leukoreduced,” and should not be
used routinely as a substitute for liquid units that are prestorage-leukoreduced via filtration. Due to processing in
an open system, the thawed and deglycerolized unit has a 24-hour shelf life.
Volume
HCT
<300 cc
70-80%
Shelf Life
10 years stored at -65º C
24 hours at 1-6ºC (after
thawing and deglycerolization)*
* Thawed, deglyced units of RBCs should be used before liquid units, since once thawed and deglycerolized, the
former have only a 24 hour shelf life.
Actions
Same as for Red Blood Cells
Indications
1.
2.
3.
4.
Patients with rare blood types.
Patients with multiple antibodies.
Patients with febrile reactions unresponsive to leukoreduced blood.
Patients with severe allergic reactions to plasma proteins (e.g., IgA-deficiency with sensitization), as these
products have been “washed” of plasma, and the red cells resuspended in saline.
5. Autologous donor transfusion (see “Special Collections” section on Autologous Donations).
Contraindications
Same as for RBCs
Potential Adverse Effects
Similar to Red Blood Cells, Leukocytes Reduced (by Filtration) with the exception that allergic reactions and
immunization to plasma proteins are reduced, and may even be prevented.
NOTE: If irradiation is needed to prevent TA-GVHD, , these products must be irradiated as well since viable
leukocytes are still present.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 10
Dosage
Depends on clinical condition; similar to RBC dosing.
Rate of Infusion
Total time of infusion should not exceed a total of four hours per unit, same as for regular RBCs.
Administration
Same as for RBCs, Leukocytes Reduced (by Filtration)
Availability
1. Two units of deglycerolized cells, requiring no special antigen typing, can be thawed and deglycerolized, and
ready for shipment by Hospital Services (HS), Tulsa, in approximately 1-1/2 hours. This is an approximate
time and does not account for time required to ship units to the ordering facility.
2. Two units of deglycerolized cells, requiring special antigen typing, can be thawed and deglycerolized, and
ready for shipment by HS, Tulsa, in approximately 4 hours. This time is an approximate time dependent on
the complexity of the antigen match required and does not account for time required to ship units to the
ordering facility.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 11
PLATELETS, RANDOM DONOR PLATELETS (RDPs), or PLATELET CONCENTRATES
Description
Platelet rich plasma (PRP) is separated from the red cells after centrifugation of a unit of WB. The PRP is
spun again and the supernatant plasma is then expressed out, leaving a unit consisting of platelets in a small
volume of remaining plasma. These units are not routinely made from donors known to have been free of
aspirin or other anti-platelet drug use in the 48 hours prior to donation. Therefore, should a single unit of
platelets, random donor concentrate (RDP) be ordered as the only unit to give, then “platelets, random donor
concentrate, leukoreduced by prestorage filtration,” which are made from donations that have been determined
to be “aspirin-free,” should be ordered (see next section).
For a description of crossmatched platelets, see section “Platelets, Pheresis-Single Donor Platelets (SDP)…”
NOTE: As of March 1, 2004, the ARCBS began performing bacterial detection on all apheresis platelets. This
new requirement was introduced in the 22nd Edition of the AABB’s Standards, section 5.1.5.1, which
states the need for “methods to limit and detect bacterial contamination in all platelet components.”
Therefore, hospitals that use RDP would need to implement some method(s) to detect bacterial
contamination of these units, or of pools of RDP, since the blood center does not test RDP. Such testing
is better performed as close as possible to the time of issue.
References: AABB Association Bulletin #03-12: “Further Guidance on Methods to Detect Bacterial
Contamination of Platelet Components” and #04-07: “Actions Following an Initial
Positive Test for Possible Bacterial Contamination of a Platelet Unit.”
Approximate Volume
45-60 ml
Platelet Count*
Storage
≥ 5.5 x 1010
@ 20-24°C, with
continuous, gentle
agitation
Shelf Life
5 days (at midnight of the
stated expiration date)
Or,
4 hours after pooling
* Southwest Region’s QC results performed monthly has a mean platelet count ranging from 8.2-8.5 x 1010.
Therefore, to equal the required platelet count in a platelet, pheresis unit (3.0 x 1011), takes about 4 units of RDP
Action
Corrects or improves abnormal hemostasis due to platelet deficiency and/or dysfunction. Thus, use is to treat
(active) bleeding or to prevent bleeding.
Indications
1. Thrombocytopenia:
a) Platelet count < 100,000, and actively bleeding or within immediate post-cardiopulmonary bypass period
b) Platelet count < 50,000, and anticipating major surgery and /or other invasive procedure
c) Platelet count < 10,000, as prophylaxis, to prevent significant bleeding
d) Platelet destruction or consumption: as in DIC, extra-corporeal circulation, chemotherapy, etc.
2. Documented platelet dysfunction (with microvascular bleeding), regardless of actual platelet count, and:
a) Actively bleeding, or
b) Surgical patient with continued or increasing “oozing” during surgical procedure, in immediate postoperative period, or if anticipating major surgery
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 12
Contraindications
1.
2.
3.
4.
5.
DO NOT use if bleeding is unrelated to decreased platelet numbers or to abnormally functioning platelets.
Usually not helpful in prophylactic treatment of ITP, immune-mediated drug purpura and hypersplenic
conditions.
Specifically contraindicated in thrombotic thrombocytopenic purpura (TTP) and heparin-related
thrombocytopenia because platelet transfusions can precipitate widespread thrombogenesis.
Relative contraindication in autoimmune thrombocytopenia.
Avoid empiric use of platelets solely based on the number of red cell units given, as in the setting of a
“massive transfusion.”
Potential Adverse Effects
Same as for RBC with the following differences:
1. Reduced to no risk for hemolytic reaction due to the minimal numbers of red blood cells present.
2. Increased risk for bacterial contamination due to room temperature storage, and possibly, also being nonleukoreduced.
3. Relatively increased risk for febrile and allergic reactions, and TRALI because of the greater plasma volume
and if pooled, presence of plasma from multiple donors.
4. Relatively reduced risk for inducing hypothermia since storage is at room temperature.
5. No risk for dilution of coagulation proteins and platelets.
6. No risk for iron overload.
Dosage
1.
2.
3.
Depends on clinical situation.
One unit of platelet concentrate usually increases the platelet count of an adult by 5,000 -10,000/ul and of a
child by roughly 20,000 or more.
The usual dose in a thrombocytopenic patient with bleeding is 1 unit per 10 kg of body weight, or 10 ml per
kg of body weight.
Rate-of-Infusion
5-10 ml/minute (~10 minutes per bag) or as rapidly as tolerated.
Administration
1.
2.
3.
4.
5.
Platelets that are ABO incompatible with the recipient's plasma may be used if not grossly contaminated with
red blood cells (crossmatching not required).
Use a standard blood component infusion set and syringe for IV push or through standard Y-type blood
component recipient set with standard in-line filter, 150 to 280 microns.
A 19-gauge or greater needle is commonly used for red blood cell transfusion. For platelet (and plasma)
infusions, a needle or catheter as small as 25-gauge can be used. Keep in mind that the smaller the needle
bore, the more likely total transfusion time will be prolonged.
A microaggregate filter should not be used. A filter to remove leukocytes is available for “bedside” use
if required, or consider using prestorage LR RDP (see next section); the latter is recommended
Except for normal saline, do not add solutions or medications to the blood, or through the same tubing during
the infusion of blood, unless such solution or medication has been approved for this use by the FDA or has
been shown and documented to be safe and to not adversely affect the blood component (AABB Standards,
23nd Edition).
NOTE: Each bag may be flushed with normal saline to maximize the number of platelets pooled or
administered.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 13
PLATELETS, RANDOM DONOR PLATELETS, OR PLATELET CONCENTRATE,
LEUKOCYTES REDUCED (by Prestorage Filtration)
Description
Whole blood from donors who have taken no aspirin or aspirin-containing medications in the prior 36 hours are
collected in a set that has 2 in-line filters. After centrifugation, the WB is separated into platelet-rich plasma
(PRP) and red cells. The PRP is filtered, centrifuged and separated into two prestorage LR units—a platelet
concentrate and a plasma unit. The red cells are filtered via the second filter, thus yielding a total of three
prestorage LR components—packed red cells, platelets and plasma. If needed, more than one of these components
may be requested for a given patient in order to limit the number of donor exposures. For this reason, these
products are ideal for neonatal transfusions.
This product is available only by ordering at least 36 hours in advance of need, or by arranging for a “standing
order” by calling Hospital Services.
NOTE: As of March 1, 2004, the ARCBS began performing bacterial detection on all apheresis platelets. This
new requirement was introduced in the 22nd Edition of the AABB’s Standards, section 5.1.5.1, which
states the need for “methods to limit and detect bacterial contamination in all platelet components.”
Therefore, hospitals that use RDP would need to implement some method(s) to detect bacterial
contamination of these units, or of pools of RDP, since the blood center does not test RDP. Such testing
is better performed as close as possible to the time of issue.
References: AABB Association Bulletin #03-12: “Further Guidance on Methods to Detect Bacterial
Contamination of Platelet Components” and #04-07: “Actions Following an Initial
Positive Test for Possible Bacterial Contamination of a Platelet Unit.”
Approximate
Volume
45-60 ml
Platelet Count*
≥ 5.5 x
Leukocyte Count
Storage
Shelf Life
< 5.5 x 105
@ 20-24C, with
continuous, gentle
agitation
5 days (at midnight
of the last day)
Or,
4 hours after pooling
(use ASAP)
1010
[ 8.3 x 105 (AABB
Standards, 23rd
Edition)]
* Southwest Region’s QC results performed monthly has a mean platelet count ranging from 8.2-8.5 x 1010.
Therefore, to equal the required platelet count in a platelet, pheresis unit (3.0 x 1011), takes about 4 units of RDP
Action
Same as for regular RDPs.
Indications
Same as for regular RDPs with addition of the following:
1. Prevent repeated episodes of non-hemolytic febrile transfusion reactions.
2. Reduce likelihood for TRALI when the recipient has putative antibodies.
3. Prevent or reduce alloimmunization to white cell antigens, thereby prevent or delay refractoriness to
platelet transfusions.
4. Reduce the risk of CMV-transmission (some controversy still exists as some physicians still accept only
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 14
5.
6.
7.
8.
serologically negative CMV-tested units)
Reduce transfusion-induced immunosuppression, and its consequences, such as post-operative
infections*
Reduce transmission of bacteria, HTLV, and Chagas disease *
Reduce reperfusion injury*
Reduce viral reactivation (e.g., CMV, HIV)*
* Potential benefits, still controversial, and not yet universally accepted or unequivocally proven—a selected
bibliography:
Blumberg N, Heal J: Blood transfusion immunomodulation—the silent epidemic. Arch Path Lab Med; Feb. 1998.
Bowden RA, Slichter SJ, Sawyer SM, Weisdorf D., et al: A comparison of filtered leukocyte-reduced and cytomegalovirus
(CMV) seronegative blood products for the prevention of transfusion-associated CMV infection after marrow transplant. Blood
1995;86:3598-3603. (landmark study).
Jensen LS, Andersen AJ, Christiansen PM, et al: Postoperative infection and natural killer cell function following blood
transfusion in patients undergoing elective colorectal surgery. Br J Surg 1992;79:513-516.
Tartter PI: The association of perioperative blood transfusion with colorectal cancer recurrence. Ann Surg 1992;216:633-638.
Van de Watering LM, et al: Beneficial effects of leukocyte depletion of transfused blood on postoperative complications in
patients undergoing cardiac surgery: a randomized clinical trial. Circulation 1998;97:562-568.
Contraindications
Same as for regular RDPs.
Potential Adverse Effects
Same as for regular RDPs with the following differences:
1.
Reduced incidence of febrile reactions, and possibly also TRALI, bacterial contamination, and allergic
reactions.
2.
Reduced risk for CMV transmission.
3.
Reduced risk for alloimmunization.
4.
Reduced effects of immune suppression (potential but not yet proven, nor universally accepted).
Dosage
Same as for regular RDPs.
Rate of Infusion
5-10 ml/minute, or as rapidly as tolerated.
Administration
Same as for regular RDPs
NOTE: Do not use a leukocyte-reducing filter or a microaggregate filter.
NOTE: The container and infusion set may be flushed with normal saline to maximize the number of platelets
administered.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 15
PLATELETS, PHERESIS or SINGLE DONOR PLATELETS (SDPs)
(including Leukocytes Reduced, HLA-Matched, and Crossmatched SDPs)
Description
Platelets, Pheresis, or single donor platelets (SDPs), are products obtained by automated collection methods that
selectively harvest platelets with some plasma and return all other portions of the single donor's blood back to the
donor. This process is referred to as “apheresis” and uses centrifugation. Centrifugation, using the differences in
the specific gravities (density) between plasma, platelets, leukocytes, and red blood cells, separates these blood
constituents, allowing for the selective collection of one or more of these components. Thus, one can collect
platelets, plasma, red blood cells, or any combination of these three. With technical modifications, apheresis
instruments are able to enhance collection of platelets or red cells while simultaneously reducing the number of
leukocytes that are shunted into the collection bag, yielding a leukocyte-reduced blood product. All apheresis
products are leukocyte-reduced unless otherwise labeled.
Specific Types of SDPs

“Standard”
Automated standard plateletpheresis products are collected from donors who have not ingested aspirin,
aspirin-containing medications or other antiplatelet drugs in the prior 48 hours. Each unit must contain at
least 3.0 x 1011 platelets (AABB/FDA requirements).

HLA Matched
Desired plateletpheresis product is collected from a donor with which recipient's HLA type has been
matched. The more desirable matches are ones in which 3/4 or 4/4 antigens match. However, 2/4
antigen matches may be the best matches available given a limited donor pool. To order this type of
product, the HLA type of the patient must be known and an order called in to Hospital Services at least
36 hours prior to need.
3.
Leukoreduced
Plateletpheresis products with < 5 x 106 WBC/mm3 are consistently obtained using current apheresis
technology. Only those units meeting this standard (AABB/FDA) can be labeled leukoreduced.

Crossmatched SDP and RDPs
SDPs, as well as RDPs, can be crossmatched with a specific patient much like crossmatching RBC units.
The patient’s serum is tested against a panel of platelets representing platelet units that are available. Turn
around time varies, depending on availability of platelet units and degree of incompatibility. For certain
situations, crossmatched platelets provide a more efficacious platelet transfusion than do HLA-matched, and
can even be “immediately” available. In addition, HLA typing of donors and patients are unnecessary.

Platelet Pheresis Products with a ‘less than standard’ platelet count
Occasionally, SDP units have a platelet content that does not meet our standard. These units are unlicensed
because of this “less than standard” platelet count; all other requirements have been met. Since the platelet
content is lower than usual, these units would be best given to patients of smaller stature (e.g., less than 70 kg
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 16
in body weight or pediatric patients), who would be expected to still attain a satisfactory increase in their
post-transfusion platelet counts.
NOTE: As of March 1, 2004, the ARCBS began performing bacterial detection on all apheresis platelets. This
new requirement was introduced in the 22nd Edition of the AABB’s Standards. Since this testing is
considered to be a “quality control” test, determination that a unit is negative is not required for release of
that unit. Therefore, a unit shipped to a transfusing facility might be subsequently determined to be
positive, that is, bacterially contaminated, after it has already been given to a patient—if this occurs, we
will notify the receiving hospital as soon as possible. Each hospital transfusion service should follow its
standard procedure/policy in the management of this type of potential event upon notification by us.
Approximate
Volume
Platelet
Count
Leukocyte Count
Storage
Shelf Life
200-500 ml
> 3 x 1011
< 5.0 x 106
(if labeled as
leukocyte-reduced)
@ 20-24C with
continuous, gentle
agitation
24 hours or 5 days, as
stated on bag label
Action
Corrects or improves abnormal hemostasis due to platelet deficiency and/or dysfunction. Thus, use is to treat
(active) bleeding or to prevent bleeding.
Indications
Same as for LR-RDP, plus: To limit the number of donor exposures that a given patient has.
In addition, indications for HLA-matched, crossmatch-compatible, etc., platelets are as follows:
1.
Patients requiring platelet transfusions and are refractory to random donor platelets and/or standard SDP:
a) If not already tried, exclusive use of ABO-specific platelets might be beneficial.
b) Use of HLA-matched products should be limited to those patients who are known to have HLAspecific antibodies that are causing the refractoriness.
c) Use of crossmatch-compatible platelets is another strategy to consider in these alloimmunized
patients. In fact, crossmatching might identify a “better” unit because crossmatching is sensitive to
antibodies directed towards HLA antigens, plus platelet-specific antigens or both.
NOTE: In addition, platelet crossmatching can be used as a “screening” tool to determine if the patient might
have alloantibodies. If the patient has a number of incompatible results, suggesting the presence of
alloantibodies, more sensitive and specific testing can then be done.
2.
Patients requiring prolonged and/or chronic platelet therapy, to prevent or reduce incidence of HLA
alloimmunization (and thus, platelet refractoriness):
a) HLA-matched products can be used, thus limiting exposure to “foreign” HLA types to which recipient
could make antibodies.
Contraindications
Same as for regular RDPs.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 17
Potential Adverse Effects
Same as for RDPs, regular or leukocyte-reduced.
Dosage
1. A single donor platelet product is equivalent to 4-6 random donor platelet units.
2. The average adult patient's platelet count will increase by roughly 25,000-80,000/mm3 after administration of
one unit.
3. During severe bone marrow aplasia, platelets may be required every second or third day.
4. With active consumption and/or destruction, more frequent administration may be needed. However, the
underlying cause needs to be corrected as repeated infusions of platelets will not correct the underlying cause.
Rate of Infusion
5-10 ml/minute, or as rapidly as tolerated.
Administration
Same as for regular RDPs.
NOTE: Do not use a microaggregate filter or a leukocyte-reducing filter with platelets labeled “leukoreduced.”
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 18
GRANULOCYTES From WHOLE BLOOD (“BUFFY COAT”) and From APHERESIS
Description
Granulocytes may be obtained via automated apheresis procedures or via "buffy coat" preparation from single
units of fresh whole blood. The latter is smaller in volume and used exclusively for neonates. For the
apheresis procedure, donors are pre-medicated with a corticosteroid (such as Prednisone®) and hydroxyethyl
starch (HES) is used during the collection. Granulocyte products usually include significant quantities of
beneficial platelets.
NOTE: Approval by the ARC Medical Director is needed when ordering granulocytes, which are
considered to require a “special order,” subject to the limitations and conditions that apply to all
special orders. Unique to granulocyte products that have a limited 24-hour shelf life, each unit
must be released per “Emergency Release” protocol. Please help facilitate the process of obtaining
the required approval (signature) from the requesting physician, or the Transfusion Service Medical
Director.
Type of Product
(Approximate Volume)
Granulocyte Count
Storage
Shelf Life
Granulocytes Pheresis*
(200-300 ml)
≥ 1.0 x 1010
(in at least 75% of units
tested)
@ 20-24oC with
NO agitation
24 hours,
preferably given ASAP
“Buffy Coat”
(50-100 ml)
(no set standards)
as above
as above
* These products also contain a significant number of platelets, effectively making these units “Granulocyte/Platelet”
Pheresis products.
Action
Enhance bacteria-fighting capabilities by supplementing granulocytes in severely neutropenic patients.
NOTE: Controversy still exists as to the clinical utility of granulocyte transfusions. More recent studies show
that the dose of granulocytes can be highly variable and cite this as the reason for the inconsistent
outcomes of earlier clinical trials. In addition, the more recent availability and use of G-CSF (such as
Filgrastim®) greatly increases the number of granulocytes that can be collected. Such granulocyte
“concentrates” could provide significant clinical benefit worthy of further investigational trials. In light
of this, the use of buffy coat-derived granulocytes becomes less desirable and even of questionable
clinical efficacy. Also, see section below, “Dosage.”
Indications
The patient should exhibit all of the following:
1. Neutropenia, <0.5 x 109/L
2. Fever for 24-48 hours, unresponsive to appropriate antibiotic therapy; or infection (including documented or
presumed sepsis) unresponsive to broad-spectrum antibiotic or other modes of therapy.
3. Bone marrow showing myeloid hypoplasia; or, absence of immature forms in peripheral blood smear.
4. Patient has reasonable chance for recovery of bone marrow function.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 19
NOTE: A period of 14 days is a rough guideline for the time required for marrow recovery (as in ablative
treatment modalities). Regardless, therapy should be attempted for at least 4 days if initiated.
Potential Adverse Effects
Same as for regular RBCs with the following additional risks:
1. High incidence of febrile non-hemolytic reactions. See Table at the end of this section for ways to
reduce the likelihood of this adverse effect.
2. May subsequently be informed that one or more tests had a reactive/positive result since transfusion must
be started prior to completion of testing.
Dosage
The efficacy of granulocyte transfusions correlates with the dosage given. The ideal dosage suggested is
equivalent to the total granulocyte pool. In the neonate, the total granulocyte pool is estimated to be 0.7-0.8 x 109
cells/kg body weight. In randomized controlled trials, the minimum effective dose was 0.2 x 109 cells/kg body
weight, and should be the minimum number used for treating granulocytopenia. Unfortunately, the leukocyte
count of the collected unit is usually not known at the time of transfusion.
Administration
1.
2.
3.
ABO identical units are preferred, otherwise units must be ABO compatible. All units must be
crossmatched and determined to be compatible because red cell content is significant.
Use a blood component/recipient set with a standard in-line blood filter.
DO NOT USE leukocyte reduction filters or microaggregate filters.
Prevention of Adverse Reactions and Events
Adverse Reactions &
Events to be Prevented
Chills and fever (non-hemolytic)
Allergic reactions
TA-GVHD
CMV seroconversion/reinfection
Measures to Take
Use slow transfusion rate; pre-medicate with antipyretics.
Adding a corticosteroid and/or antihistamine may be helpful.
Premedicate with an antihistamine; adding a corticosteroid may
be helpful.
Irradiate (preferably just before transfusion)
Use CMV seronegative, repeat donors for babies whose mothers are
seronegative or for the patient who is seronegative.
(Leukoreduction by filtration is contraindicated since the desired component,
granulocytes, would be reduced to non-therapeutic levels.)
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 20
FRESH FROZEN PLASMA (FFP)
Description
Single donor plasma frozen within 8 hours of collection and stored at -18C or colder, obtained from separating
the plasma from a unit of WB or collected concurrently during a pheresis collection. FFP still contains leukocytes,
though much fewer than in cellular components (< 104 versus up to 106, as in LR-SDP). A prestorage
leukoreduced (LR) plasma product is available as one of the components created during the production of a
prestorage LR RDP.
Approximate
Volume
Concentration
(by definition)
Storage
Shelf Life
200-300 ml
Factor VIII
(and other coagulation
factors):
1 IU/ml
≤ -18°C
1 year
1- 6° after thawing
*24 hours after thawing
Fibrinogen:
1 mg/ml
(plus all plasma constituents
circulating in blood)
Pediatric Units with volumes of 80-100 ml/bag are available on request ("Pedi-paks").
* When FFP is used as source of labile coagulation factors. However, if use for coagulation factor deficits other
than Factor VIII or V, can be used as “liquid or thawed plasma” for up to 5 days after thawing if stored at 1-6° C.
Actions
1.
2.
Provides coagulation factors for treatment of most coagulation factor abnormalities (deficiencies or
dysfunctions), for which no factor concentrates are available.
As replacement fluid in therapeutic plasma exchange for TTP/HUS.
Indications
1. Suspected or proven coagulopathy, with active bleeding and:
a) PT and/or PTT > 1.5 times normal control, or INR > 1.5, or
b) Secondary to massive transfusion (≥ one TBV) with documented coagulation abnormality
2. Active or anticipated bleeding, as pre-operative or pre-procedural prophylaxis of patients with:
a) Deficiency (<30% of normal) of a coagulation factor for which specific coagulation factor concentrate is
not available, e.g., factor XI deficiency
NOTE: Isolated deficiency of F XIII or fibrinogen is usually treated with cryoprecipitate though frozen plasma
can be used.
b) Deficiency of multiple factors
c) Documented (rare) specific plasma protein deficiencies such as C1-inhibitor, or protein C or S
deficiencies.
3. Reversal of warfarin therapy when an urgent invasive procedure is imminent or patient is actively bleeding,
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 21
and vitamin K-reversal is unacceptably too slow or inadequate for the clinical situation.
4. As the replacement fluid used in the therapeutic plasma exchange (TPE) of patients with thrombotic
thrombocyopenic purpura (TTP) or hemolytic uremic syndrome (HUS). NOTE: Some experts recommend
the use of plasma in which large multimers of vWF are reduced or absent, such as “cryo-poor FFP.”
NOTE: The selective use of an available, specific factor concentrate is always the “first choice” since these have
been virally inactivated. As an option, recombinant preparations are also available and also pose no
transfusion-transmissible infectious disease risk.
Contraindications
1. Do not use when coagulopathy can be corrected with a specific, safer, and effective therapy such as
Coagulation Factor VIII Concentrate for F VIII deficiency, or vitamin K administration for reversal of
warfarin effects.
2. Do not use as a routine volume expander.
3. Do not use as a source of nutrition (i.e., protein).
Potential Adverse Effects
Same as for regular RBCs with the following differences:
1. Risk for hemolytic reaction resides in the possibility of donor antibody directed towards patient red cell
antigen, an infrequent occurrence.
2. Reduced to no risk for TA-GVHD; most standard practice is that irradiation is not indicated
3. Rarely, causes a positive direct antiglobulin test
4. No risk for iron overload. However, when used in huge quantities, such as during TPE, citrate can cause
symptomatic hypocalcemia.
5. Bacterial contamination can occur during the thawing process. Some recommend routine double over-wrap of
all units before thawing in a water bath, in addition to meticulous, routine cleaning of the water bath.
Dosage
Depends on the clinical situation and patient size, and may be determined by serial laboratory assays of
coagulation function; usual "dose" is 2 units (for adults), or about 5-20 ml/kg body weight A unit contains
approximately 5-6% of all necessary clotting factors for an average adult (70 kg).
Rate of Infusion
Four to ten ml/minute or as rapidly as patient can tolerate.
Preparation and Administration
1.
Must be ABO compatible with the recipient’s red cells (however, compatibility testing is not required).
Patient
FFP/plasma components
O
A
B
AB
A, B, AB, O
A, AB
B, AB
AB
NOTE: Group AB is the “universal donor” of plasma components
(e.g., FFP, cryo).
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 22
3.
4.
Thaw product between 30-37°C with gentle agitation (approximately 30 minutes). Use overwrap to
avoid contamination of entry ports if possible.
Use a standard blood infusion set: Y-type tubing with blood component filter or straight tubing with
blood component filter (150-280 microns).
NOTE: Pediatric aliquots (approximately 90ml/bag) are available upon request.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 23
FRESH FROZEN PLASMA (FFP), JUMBO
Description
Single donor plasma frozen within 8 hours of collection and stored at -18C or colder, are obtained by automated
apheresis collection methods that may also concurrently harvest platelets and/or red cells. All other portions of
donor blood are returned to the donor.
Approximate
Volume
500 ml
Concentration
(by definition)
Storage
Shelf Life
Factor VIII (and other
coagulation factors):
1 IU/ml
≤ -18°C
1 year
1-6°C after thawing
*24 hours after thawing
Fibrinogen:
1 mg/ml
(plus all plasma
constituents circulating in
blood)
* When FFP is used as source of labile coagulation factors. If use for coagulation factor deficits other than Factor
VIII and V, can be used as “liquid or thawed plasma” for up to 5 days after thawing if stored at 1-6° C.
Action
Same as for FFP.
Indications
Same as for regular FFP with the following additions:
1. Decrease donor exposure.
2. More convenient to use in therapeutic plasma exchange.
NOTE: The selective use of an available, specific factor concentrate is always the “first choice” since these have
been virally inactivated. As an option, recombinant preparations are also available and pose no
transfusion-transmissible infectious disease risk.
Contraindications
Same as for FFP.
Potential Adverse Effects
Same as for FFP but with possible increased risk for volume overload.
Dosage
Depends on the clinical situation and patient size, and may be determined by serial laboratory assays of
coagulation function. The usual "dose" is 1 unit (for adults) since total volume is about twice the volume of a
single unit of “regular” FFP. Generally, 5-20 ml/kg body weight is needed to increase factor levels to
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 24
concentrations sufficient to achieve hemostasis. A unit contains approximately 10% of all necessary clotting
factors for an average adult (70 kg).
Rate of Infusion
Four to ten ml/minute, or as rapidly as patient can tolerate.
Preparation and Administration
Same as for FFP.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 25
PLASMA FROZEN WITHIN 24 HOURS (FP)
Description
Single donor plasma, separated from a unit of WB, is frozen within 24 hours of collection and stored at -18°C or
colder. These units are essentially the same as FFP but with slightly decreased amounts of Factors V and VIII, the
“labile” coagulation factors. The loss of F VIII is greater than that of F V. The quantity “lost” is almost always a
non-issue in terms of potency since isolated F VIII deficiency should be treated with virally-inactivated or
recombinant F VIII concentrates rather than frozen plasma of any type.
Approximate
Volume
Concentration
(by definition)
200-300 ml
Factor VIII:
< 150 IU/U
Storage & Shelf Life
Same as for FFP
Other labile and stable coagulation factors at
levels comparable to that of FFP
(plus all plasma constituents circulating in blood)
Actions
Provides plasma proteins including all coagulation factors, with Factor V and VIII at concentrations slightly lower
but comparable to FFP (see above, under “Description”).
Indications
Same as for FFP.
NOTE: The selective use of an available, specific factor concentrate is always the “first choice” since these have
been virally inactivated. As an option, recombinant preparations are also available and pose no transfusiontransmissible infectious disease risk.
Contraindications
Same as for FFP.
Potential Adverse Effects
Same as for FFP.
Dosage and Rate of Infusion
Same as for FFP.
Preparation and Administration
Same as for FFP.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 26
FROZEN PLASMACRYOPRECIPITATE REDUCED
Description
Frozen plasma from which cryoprecipitate (see next section) has been removed—a unit of plasma that is
“cryo-poor.” This product has very low to essentially no amounts of F VIII, F VIII:vWF, fibrinogen, and F
XIII. Otherwise, the constituents in this product are the same as those found in FFP.
Approximate
Volume
Concentration
(by definition)
200-300 ml
Labile and stable coagulation factors at
levels comparable to that in FFP with the
exception of: F VIII, F VIII:vWF,
fibrinogen, and F XIII
Storage & Shelf Life
Same as for FFP
(plus all plasma constituents circulating in
blood)
Action
Provides plasma proteins including all coagulation factors, with the exception of the coagulation factors listed
in the above table.
Indications
Single clinical use for this product is as replacement fluid in TPE of patients with TTP. For those who
espouse this use, the claim is that this product has essentially no large multimers of von Willebrand factor, a
molecule that has been proposed to cause TTP, or at least for some cases of TTP. Clinical studies have not
consistently supported a greater benefit from using cryo-poor plasma versus ‘regular’ frozen plasma in the
TPE treatment of TTP.
Contraindications
Same as for FFP, with the following addition:
Deficiencies of fibrinogen, vWF, or F XIII, since this product is itself deficient in these factors.
Potential Adverse Effects
Same as for FFP
Dosage
Same as for FFP
Rate of Infusion
Same as for FFP
Preparation and Administration
Same as for FFP
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 27
CRYOPRECIPITATED AHF (“Cryo”)
Description
A preparation that contains anti-hemophilic factor (AHF or Factor VIII), consisting of the cold, insoluble portion
obtained from thawing a unit of FFP. AABB Standards specifies that cryo is to be prepared by a method that
results in a minimum of 150 mg of fibrinogen and at least 80 IU of F VIII.
Approximate
Volume
10-15 ml
Concentration
(by definition and by
QC testing)
Storage
Shelf Life
Factor VIII:
≤ -18°C
1 year
@ 20-24°C after
thawing
6 hours after thawing
OR
4 hours if pooled
(“open system”)
 80 IU/bag
Fibrinogen:
 150 mg/bag
Action
Contains only coagulation Factors VIII:C, VIII:vWF (von Willebrand factor), XIII, and fibrinogen; used to
control bleeding episodes due to a deficiency of one or more of these factors. Especially useful in fibrinogen
deficiency or dysfunction when volume overload is an increased risk. (Also contains fibronectin for which a
therapeutic use has not been established.)
Indications
1. Fibrinogen deficiency (<100 mg/dL) or fibrinogen dysfunction, regardless of quantity, and:
a) Patient is actively bleeding
b) Patient is facing urgent surgery or an invasive procedure with increased risk for bleeding (i.e.,
prophylactic use)
[Hypofibrinogenemia or dysfibrinogenemia may be associated with DIC, hepatic insufficiency, or even massive
transfusions. Treating the underlying condition should be adequately addressed as well.]
2. Factor XIII deficiency and:
a) Patient is actively bleeding
b) If facing surgery or other invasive procedure and level is < 5%, prophylactically
3. Patients with von Willebrand’s disease (vWD) should be treated with cryo:
a) ONLY when appropriate F VIII concentrates or F VIII concentrate containing vWF are not available,
and
b) when the patient has known history of unresponsiveness to DDAVP (desmopressin), or
c) patient is unresponsive to a trial with DDAVP
4. Topical use as “fibrin sealant”—however, virally inactivated products preferable when available
NOTE: Lab studies supporting need for transfusion should be documented. The selective use of an available
specific factor concentrate is always the “first choice” since these have been virally inactivated. As an
option, recombinant preparations are also available and, even better, pose no transfusion-transmissible
infectious disease risk.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 28
Contraindications
Do not use unless results of laboratory tests indicate specific coagulation deficit for which this product would be
beneficial.
Potential Adverse Effects
Same as for FFP with the additional risk for hyperfibrinogenemia especially when given to a patient without
hypofibrinogenemia.
Dosage
1.
Coagulopathy - depends on clinical situation; usual dose is one unit per 7-10 kg body weight, or for the
average adult patient, about 10 units.
2. Specifically for fibrinogenemia: one unit per 10 kg body weight raises fibrinogen concentration by ~50
mg/dL in the absence of continued consumption or loss, as in massive bleeding.
3. *Hemophilia A - dependent on patient and clinical situation. Dosage can be calculated as follows:
 70ml/kg x Body Weight (kg) = Total Blood Volume (ml)
 Total Blood Volume (ml) x (1 - hematocrit) = Plasma Volume (ml)
 (Desired Factor VIII level - initial Factor VIII Level) (units/ml) x Plasma Volume (ml) = units of Factor
VIII needed
 With a minimum of 80 IU of Factor VIII in one bag of cryo, the number of bags of Cryoprecipitated
AHF needed =units of Factor VIII needed  80
 To maintain hemostatic levels, repeated Factor VIII transfusions need to be given at 8-12 hour intervals,
due to the 12-hour half-life of Factor VIII. An alternative to periodic bolus administration is a slow,
constant infusion over an 8-12 hour period.
 The above calculation can also be used for any other coagulation factor deficiency, with frequency of
dosing dependent on the half-life of that specific coagulation factor.
4. *von Willebrand's disease - Smaller amounts of Cryoprecipitated AHF will usually correct the deficit.
* NOTE:
Other treatment options should be utilized first! See "Indications" above.
5. Topically, to enhance hemostasis, used as “fibrin glue”; specific volume is ordered, usually 10-30 cc (up to 6
bags), which is then mixed with thrombin just before application on bleeding site. However, virally
inactivated products are preferable when available.
Rate of Infusion
As rapidly as tolerated (about 10 ml per minute).
Preparation and Administration
1.
2.
3.
4.
5.
6.
Does not require ABO compatibility and crossmatching is not required; Rh type can be ignored.
Thaw rapidly at 30-37C (up to 15 minutes).
Store at room temperature until transfused because refrigeration may encourage re-precipitation of the
concentrated Factor VIII.
Cryoprecipitated AHF must be administered within 6 hours of thawing or 4 hours of pooling (“open
system”), whichever is shorter.
Do not refreeze after thawing.
Use standard blood component infusion set and syringe for IV push or standard blood component recipient
set for infusing pooled cryo.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 29
BLOOD PRODUCTS for NEONATAL/PEDIATRIC PATIENTS
Because neonatal and pediatric patients require smaller volumes of blood for their transfusion needs, the
Southwest Region provides red cells, fresh frozen plasma and random platelet concentrates in bag configurations
that allow a single unit to be dispensed in multiple aliquots until their expiration date. These special products have
been split into smaller than normal-sized bags, or have satellite bags attached, so that small aliquots can be made at
the time of need by the hospital transfusion service. Either configuration, by maintaining a closed system for the
entire shelf-life, allows a single unit to be available for multiple transfusion needs of a given baby, thus limiting
the number of donor exposures. Aliquots also eliminate wastage of unused portions of units when only a small
volume is needed. To obtain such products, a standing order for those facilities that use these products routinely,
can be arranged through Hospital Services. Otherwise, these products are available only by special order, usually
with a minimum delay of 36 hours.
Red Cells or Whole Blood:

Typically from an O negative donor, and routinely leukoreduced. May be collected with customized
specifications, such as CMV negative, # of satellite bags attached, anticoagulant desired, etc.
 Units can be drawn as either CPDA-1 units with an outdate of 35 days, as AS-3 units with a 42 day shelf-life,
or in Optisol®, also with a 42 day shelf-life. For routine (small) transfusion needs, RBC can be used up to
expiration date.
 All units are prestorage leukoreduced (which some do consider to be “CMV-attenuated”). However, CMV
testing can be done upon request or as a standing order, if seronegative units are desired.
 If packed red cell units are desired, a minimum of 2 satellite bags can be attached to provide a closed system
that the hospital blood bank can aliquot into smaller portions. Once an aliquot is entered, the expiration date
for that aliquot is 24 hours from time of entry. However, the primary bag retains the full shelf-life.
NOTE: The suggested red cell component of choice for small volume transfusions (5-10 ml/kg BW) is a
prestorage leukocyte-reduced RBC unit in AS-3, group O/Rh negative or positive, and used until its
outdate. For transfusions requiring large volumes, such as for exchange transfusions, most experts still
prefer using CPDA-1 units that do not have an additive solution.
Fresh Frozen Plasma:



Hospital Services routinely supplies group AB "pedipaks" upon request. A fresh frozen plasma is processed
so that the plasma is usually split into 3 bags of approximately 90 ml each (the actual volume is noted on each
bag).
Expiration date of a frozen unit is one year from collection, stored at -18oC or colder.
Units should be thawed in the same manner as for standard sized fresh frozen plasma. After thawing,
expiration is 24 hours from thawing time when used as a source for labile coagulation factors (AABB
Standards), or up to 5 days if kept at 1-6o C, but is to be used only as a source for non-labile coagulation
factor(s).
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 30
IRRADIATED BLOOD COMPONENTS
Description
Irradiation of blood products containing viable leukocytes is indicated whenever the recipient is at risk for
transfusion associated-graft-versus-host-disease (TA-GVHD), such as for certain immunoincompetent or
immunocompromised patients. In addition, any directed unit from a donor who is a blood relative of the intended
recipient requires irradiation, as do all HLA-matched platelets and crossmatch-compatible platelets. These latter
indications are ones that are “automatically” irradiated by the ARCBS, unless otherwise requested (AABB/FDA
requirement).
Cause of TA-GVHD
With the transfusion of a blood product, infusion of viable leukocytes, specifically lymphocytes, is inevitable with
the exception of a few blood components that contain essentially no white blood cells (such as frozen plasma and
cryo). In particular, engraftment by viable allogeneic donor T lymphocytes (T-cells) is most likely in an
immunocompromised recipient who is unable to destroy these alien cells from the allogeneic donor. These
allogeneic T-cells continue to survive in the recipient, may multiply and mount an attack against the recipient’s
cells, recognized as alien by the donor T-cells. Thus a “graft (donor)” versus “host (recipient)” process begins.
Although TA-GVHD is rare, when it develops it is highly fatal with a fatality rate in excess of 90%. The
minimum lymphocyte dose thought capable of inducing TA-GVHD in a susceptible host is approximately 107 Tcells/kg body weight. Adequate irradiation of whole blood and blood components destroys the replicative
potential of T-cells and hence precludes engraftment and subsequent formation of antibodies against host cell
antigens. Investigative studies of TA-GVHD in bone marrow transplantation cases support the contention that
both helper/inducer and suppressor/cytotoxic T-cells are necessary for TA-GVHD. However, the complete
explanation is still not known.
In the situation in which the blood donor is a blood relative of the recipient, TA-GVHD can occur in an identical
process to the above without the recipient being immunocompromised. Because of the common inheritance of
specific “cell markers” (antigens), a greater chance exists that the recipient and donor share the same antigens.
Unfortunately, should the recipient express antigens not found in the donor, donor T-cells will recognize these as
foreign and mount an attack on the recipient’s cells and organs.
(Anderson KC, Weinstein JH: Transfusion-associated graft-versus-host disease. NEJM 1990;323:315-321)
Indications
1.
2.
3.
4.
5.
6.
7.
8.
Bone marrow/stem cell transplantation recipients or candidates for bone marrow/stem cell transplants
Congenital immune deficiency syndromes.
Intrauterine (fetal) transfusion, including newborns who had received intrauterine transfusion
Exchange transfusion of newborns
Patients with acute leukemia of lymphoma (including Hodgkins disease)
Directed donation from person who is a blood relative of the intended recipient (see below).
Platelet apheresis product donated by HLA-histocompatible donor (i.e., an HLA-matched platelet pheresis
donor).
Crossmatch-compatible platelets
NOTE: Other indications are still controversial with practice varying among physicians (see following section).
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 31
NON-Indications
Acquired immunodeficiency syndrome (AIDS) is not an indication, because TA-GVHD has not been reported in
AIDS patients. Similarly, patients with solid tumors undergoing chemotherapy or radiation therapy and patients
with aplastic anemia are not thought to be susceptible to TA-GVHD. Patients with chronic granulomatous disease
have normal immune system function and do not require irradiated products either.
NOTE: When irradiation is indicated, all cellular components should be irradiated. Irradiation of cryoprecipitate
and frozen plasma is not usually done; however, studies showing rare numbers of what appear to be
viable lymphocytes are cited by those who order irradiation of these products. Though TA-GVHD has
not bee reported to occur with deglyced RBCs, viable lymphocytes have been reported to be present, and
these products may need to be irradiated.
Irradiation of Directed Donations
AABB Standards recommends irradiating all directed donations from blood relatives. The Southwest Region,
American Red Cross, Medical Advisory Committee (local pathologists and other community physicians) has
agreed that all directed donations from blood relatives will be irradiated prior to distribution to the hospitals. The
only exception to this will be units sent to hospitals that have informed us, in writing, that they will perform their
own irradiation.
IF A HOSPITAL PREFERS TO PERFORM ITS OWN IRRADIATION, PLEASE CONTACT HOSPITAL
SERVICES AT THE LOCATION NEAREST YOU, IF YOU HAVE NOT ALREADY DONE SO.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 32
PLASMA DERIVATIVES
UNTIL FURTHER NOTICE, the following information is still in effect:
To order American Red Cross Plasma Protein Fraction, Normal Serum Albumin, Immune Globulin Intravenous,
Antihemophilic Factor or AlphaNine (Factor IX) please call the national distribution center in Louisville,
Kentucky. Various ways to access this national distribution center is as follows:
ORDER / CUSTOMER SERVICE - VOICE
(800) 261-5772
ORDER / CUSTOMER SERVICE - FAX
(800) 261-5773
HOURS OF OPERATION
0800 - 1800 Eastern Time
REMIT - TO ADDRESS
MEDICAL DISTRIBUTION, INC.
POST OFFICE BOX 18230
LOUISVILLE, KY 40261
If the above is “No longer in service,” please call BAXTER at: (800) 423-2090. With the closing of ARCBS’
Plasma Services, Baxter has been identified as the future source for plasma derivatives. Red Cross-collected
plasma will be shipped to Baxter for further manufacture into plasma derivatives.
The following pages contain information about Rh Immunoglobulin (RhIG) and Varicella Zoster Immunoglobulin
(VZIG). The American Red Cross Blood Services, Southwest Region, is no longer stocking any plasma
derivatives, RhIG, or VZIG, or disposable supplies such as blood administration sets, filters, satellite bags, etc., for
routine distribution. Other than the above source, hospitals are advised to check with their pharmacies, purchasing
office, or other supplier/vendor to acquire any of these needed products or supplies.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 33
Rh-IMMUNE GLOBULIN (RhIG)
Description
Rh-immune globulin is prepared from human donors, immunized to Rh-positive red blood cells, and therefore
are producing antibody directed against the Rh D-antigen. Products available today have undergone viral
inactivation steps of one type or another, dependent on the manufacturer. Two forms are available: one for
intramuscular (IM) injection, the other for intravenous (IV) administration.
NOTE: Refer to manufacturer's insert for the most current information.
Strength
Storage
Shelf Life
See manufacture’s package
insert
See manufacture’s package
insert
See Expiration date on product
Action


Attaches to Rho (D) antigens present on the surfaces of red blood cells causing their removal from circulation
and eventual destruction, primarily within the spleen.
Each 300g Rh immune globulin dose is directed against a maximum of 15ml of Rh-positive red blood cells,
or 30cc of Rh positive whole blood.
Indications
1. To prevent alloimmunization towards the Rho (D) antigen, thus preventing anti-D antibody production. For
example:
2. To prevent alloimmunization in a pregnant woman who is Rho (D)-negative and who has just delivered an Rh
positive baby, thus eliminating the risk for hemolytic disease of the newborn in her subsequent pregnancies.
3. To prevent alloimmunization when an Rh-negative person, with no known anti-D antibody, has been exposed
to a significant quantity of Rh-positive red blood cells. This is especially critical if the patient is female and of
child-bearing age. If numerous IM injections might be detrimental to the patient, consider using the
intravenous formulation, described below.
4. In patients with ITP, an intravenous form of anti-D immunoglobulin (e.g., WinRho®) adheres to the D
antigen of red cells; subsequent “blockage” of the reticuloendothelial system prevents further destruction of
platelets. (This form of RhIg was licensed by the FDA for the specific treatment of ITP; other clinical uses
would be “orphan drug” type usage.)
Contraindications
1.
2.
Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not
receive RhIG.
Presence of severe thrombocytopenia is a relative contradiction to the use of the IM formulation; may need to
consider use of intravenous form of RhIG in order to avoid prolonged bleeding if patient were to need
multiple, repeat intramuscular injections.
Potential Adverse Effects
See manufacturer's package insert.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 34
Dosage
1.
2.
3.
The usual dose for indications associated with pregnancy is 300 g, unless there is clinical or laboratory
evidence of a fetal-maternal hemorrhage in excess of 15ml of Rh positive red blood cells. Please refer to
package insert for proper dosing.
For “inadvertent” exposure of an Rh negative patient to Rh positive red cells, RhIG dosing depends on the
volume of Rh positive red cells infused, using 300 g for each 15 ml of Rh positive RBCs received.
For all other indications, refer to manufacturer’s package insert.
Administration
Refer to manufacturer’s package insert
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
VARICELLA ZOSTER IMMUNE GLOBULIN (VZIG)
Description
Hyperimmune globulin (IG) directed against varicella zoster virus, the causative agent of chicken pox and
shingles.
NOTE: Please refer to the manufacturer’s package insert for the most current information.
# of units/Vial (Total Volume)
125 units/vial (ml)
625 units/vial (~ 6.25 ml)
Storage
Refer to manufacturer’s
package insert
Shelf Life
See expiration date on product.
Indications
1.
2.
3.
Provides passive immunization against varicella zoster in the immunosuppressed patient and may modify
clinical disease in those with significant varicella zoster exposure.
Most effective when given within 96 hours of exposure.
Refer to manufacturer's insert for more current indications.
Contraindications
1.
2.
Should not be administered to individuals having a history of severe reactions following administration of
immunoglobulin.
In those with thrombocytopenia, need to consider risk:benefit ratio before administering this product as it is
given intramuscularly.
Potential Adverse Effects
See manufacturer's package insert.
Dosage
Based on body weight (also refer to manufacturer’s current package insert):
WEIGHT of PATIENTS:
Kilograms
Pounds
0-10
0-22
10.1-20
22.1-44
20.1-30
44.1-66
30.1-40
66.1-88
Over 40
Over 88
DOSE:
Units
125
250
375
500
625
Number of Vials
1 - 125 unit vial
2 - 125 unit vial
3 - 125 unit vial
4 - 125 unit vial
1 - 625 unit vial or 5 - 125 unit vial
From MASS. Public Health Biologic Laboratories’ Insert Revised January 1996
Administration
Refer to manufacturer’s package insert
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
Page 1
ORDERING BLOOD AND BLOOD PRODUCTS
Information Needed When Placing an Order:
Name of hospital
Name of person placing the order
Specific product(s) requested.
Number of units.
Blood group and Rh, if appropriate.
If order is for a specific patient: name of patient, requesting physician, patient status, and surgery date
if applicable.
Transportation arrangements.
Nature of request e.g., ‘for stock,’ ASAP, or ‘to give’
“STAT” REQUEST:
Used to describe a situation for which unnecessary delay in the provision of services requested will endanger the
life of a patient.
Whenever this type of request is made, it is implied that no product (crossmatched or otherwise) exists in the
hospital's inventory suitable to meet the need. The order does not necessarily imply that the units delivered will be
transfused. However, short-dated units will usually be dispatched, instead of fresh units.
When the size of the order and blood supply permits, "Stat" orders are generally processed and delivery initiated
within 30 minutes of the call. When we know a life depends on the blood order, the courier dispatcher (who is
called upon receipt of the order) can tell the order clerk if the company can meet the time standard. If they cannot,
staff, volunteer, or back-up sources will be dispatched in order to ensure prompt delivery.
“AS SOON AS POSSIBLE” (ASAP) REQUEST:
Used to describe a situation in which the routine delivery procedure, in the estimation of the person placing the
order, will not be suitable due to certain time factors involved. To help us meet your expectations, please specify
desired timelines at the time of the request.
SURGERY REQUEST:
An order for a sufficient quantity of blood products that meet the anticipated blood needs of an upcoming surgery
or for the post-operative needs of a patient.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
Page 2
Since open heart surgery orders are usually called a day in advance, routine scheduled delivery to local hospitals is
used. Otherwise, the intended time of surgery should be clearly defined so that delivery can be made in sufficient
time to allow for pretransfusion testing by the hospital.
STOCK REQUEST:
Used to order a quantity of blood products that ensures the maintenance of a predetermined number of units as that
hospital's inventory.
The word “stock” is variably interpreted by each hospital. Some use it to describe available units, and do not
include units that are crossmatched. Others include all units on hand as “stock” inventory without regard to
whether a particular unit is crossmatched or not. During blood shortages, Hospital Services will notify hospitals if
stock orders will have to be reduced. HS will fill stock orders at its discretion in order to ensure an efficient,
region-wide system that recognizes and is able to respond to orders of an urgent nature requiring prompt delivery.
Only through open communication and the cooperation of the hospitals that ARC serves, will optimal management
of the valuable resource that blood is, be maintained.
TRADE-OUT INVENTORY:
Used to describe the exchange of inventory units with shorter dating for units that are fresher, with a longer shelflife. Hospitals receiving delivery less frequently due to their location and/or low usage rate, "trade-out" inventory
through the recently revised regional distribution system.
"TO GIVE" REQUEST:
Used to obtain the specific number and type of units ordered by a physician for transfusion to a specific patient.
When ordering “to give” blood, please inform HS of any urgent time lines so that HS staff can better triage and
prioritize orders received.
Since the probability for transfusion is very great, it is often feasible to utilize units nearing their expiration date.
It is understood, unless otherwise stated, that the hospital placing such an order will accept short-dated inventory.
In fact, such requests do not automatically indicate that the ordering hospital does not have in its inventory, units
that meet the physician’s request. Rather, this ordering practice allows hospitals to use up short-dated inventory
wherever those units might be in the region. The end result is the conservation of “fresher” units in hospital
inventories and the prevention of unnecessary wastage due to outdating of blood. Since this utilization of shortdated products will not compromise patients, routine use of short-dated products for “to give” orders maintains the
goal of optimizing the use of quality blood as well as optimal management of this valuable community blood
supply.
.
Other Communication Options:
Police Department or Highway Patrol Radio Systems - are to be used when all telecommunications fail.
NOTE: As part of the ARC national system, all Blood Services regions are included in the communications and
subsequent coordination of resources should any major disaster or biological terrorist act occur. This
encompasses disaster aid of all types, potential re-distribution of blood to affected sites in need, and even
to modifications in blood collections if determined to be necessary. During such events, the involvement
of all hospitals is critical. The very important early actions to take include: determining the inventory of
all available group O RBCs in the region, estimating the number of possible victims, determining if
sufficient blood is available, and then coordinating any needed re-distribution of available blood
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
Page 3
products. [For more information, refer to the AABB’s Interorganizational Task Force on Domestic
Disasters and Acts of Terrorism’s Disaster Operations Handbook: Coordinating the Nation’s Blood
Supply During Disasters and Biological Events (2003)—posted on its web site: www.aabb.org.]
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
Page 4
RETURN AND TRANSFER POLICIES
NOTE: Since changes in For Returns (Refer to the return policy implemented in September 2003), almost all
“returns” from hospitals are actually being transferred directly to other hospitals, specifically those
with high usage rates, rather than being returned to the ARC. Credits and charges, if applicable, are
appropriately made to the respective hospitals. Specific details are noted below.
For Returns (Refer to your facility’s most recent blood services contract for any exceptions to the following
general policies):
1. As a general rule, the ARC will not accept the return of in-dated products for re-issue. Instead, Hospital
Services will attempt to locate a hospital that these units may be transferred to. However, under special
circumstances, the ARC will accept the return of in-dated products for reissue. These cases should be preauthorized and approved by local Hospital Services management or the Regional Hospital Services Manager.
With pre-authorization, the return and possible re-issue of blood will be facilitated.
2. The ARC will continue to accept products being returned for quality issues as determined by the hospital.
These products will be investigated by ARC in case the cause is a manufacturing deficiency that needs
correcting.
3. The ARC will extend credit for outdated products on a predetermined basis. Please review the current blood
services contract or contact the Regional Account Manager to determine credit policies for specific product
types.
4. In the event a product needs to be returned to the ARC, the following protocol will be followed:
a)
Contact your local Hospital Services location and request pre-approval for the return of the product(s)
being returned.
b)
A member of Hospital Services will contact you to ascertain key pieces of information about the
product you are requesting pre-approval for return. A Hospital Services member will inform you if
your product qualifies for return or not.
c)
If the products qualify for return, a member of Hospital Services (or the courier) will be dispatched to
your facility with a Return Authorization Form and a Return Label.
d)
Complete Section 2 of the Return Authorization Form and place in the top of the box with the products
being returned.
e)
Label the shipping box with the Return Label so that it is clearly marked as a “returns” shipping box.
f)
Give the shipping box to the Hospital Services staff member or courier for transport.
NOTE: All returns to the ARC must be pre-approved by a member of Hospital Services Management. The ARC
only allows return of blood or blood products that meet one of the following requirements:
 The returned product can be reissued or further manufactured for reissue (has no apparent quality or
safety defects).
 The returned product is requested by the ARC.
 The returned product has quality issues, usually identified by hospital staff that must be investigated.
In contrast, the following are not accepted for return to the American Red Cross or for transfers:
 Outdated and frozen products.
 Any products (bag label) that have been defaced cannot be transferred or returned for credit.
Any deviation from this protocol could result in the unnecessary destruction of blood or blood products.
In this event, credit will not be extended for those returned products.
For Transfers:
1. Traceability of all blood products is a requirement of the Food and Drug Administration. Therefore, proper
documentation of such transfers, including temperature and storage conditions at time of receipt, is of utmost
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
Page 5
importance. For this documentation, a Transfer Form should be completed. Keep the appropriate copy for
your record and send the appropriate pages of this form with the products transferred. The receiving hospital
will document receipt of products by signing the form and returning the black and brown pages to the Red
Cross.
2. When transferring between hospitals, products should be packaged the same as for returns. Upon receipt,
temperature of the products should be documented. ARC must be involved with any transfer of any blood
product to ensure traceability to the product’s final destination.
3. Blood should not be transferred with a patient unless it is to be transfused in route. In this case, the hospital
transferring the patient should charge the patient for processing fees. Paperwork does not need to accompany
the blood, as there is no guarantee that the units will remain in a controlled temperature or environment. If the
receiving hospital receives blood transferred with a patient, it may be disposed of properly by the receiving
hospital or returned to Red Cross for proper destruction. The unit will be charged to the transferring hospital.
4. The following policies apply with regard to the specific products to be transferred:
a)
received as a transfer but outdate.
Note: RBCs/LRBCs with less than two integrally attached segments will not be accepted for transfer or credit.
b)
c)
d)
e)
f)
g)
h)
Autologous units cannot be transferred unless the patient they were collected for is transferred as well.
Autologous units can be used only by for the patient who is named on the label. Therefore, these units
should be destroyed if not used, preferably by the hospital. No credit will be given for unused units if
originally billed to the hospital.
Directed donation units should be held by the hospital for use by the intended recipient for as long as
the hospital policy states. If still in-date at the end of that time, they should then be released, entered
into inventory for general use and considered as regular allogeneic units. Irradiation of directed
donation units shortens their shelf life, but otherwise are perfectly safe to use. However, no credit will
be given for the Directed Special Handling Charge regardless of the final disposition of a directed
donation unit.
Requests for fresh frozen plasma and cryoprecipitate to be transferred for credit can be made if the
products have a minimum of sixty days until outdate, have not been thawed and re-frozen, and have
been stored according to all applicable regulations in a monitored freezer. Credit will also be issued if a
unit breaks despite proper handling. The whole blood number of each unit being transferred should be
entered on the Transfer Form and transfer form forwarded to Hospital Services.
Products that have been specially ordered/prepared (for example: deglycerolized red cells,
granulocytes/buffy coat, or irradiated products) may only be transferred under special circumstances and
must be pre-authorized by local HS ARC management or the Regional Hospital Services Manager.
Products that have been screened for special antigens (red cell antigens or HLA) may only be
transferred under special circumstances and must be pre-authorized by local HS management or the
Regional Hospital Services Manager. No credit will be issued for the antigen screens performed or any
other associated testing involving these “special” units.
Random donor platelets can be transferred only if stored at monitored temperatures (20° - 24°C),
rotation/agitation has continuously occurred and the product has at least 24 hours shelf life remaining
(unless other arrangements have been made). Approval for return must be obtained from the local
Hospital Services management or the Regional Hospital Services Manager.
Platelet, apheresis can be transferred only if stored at monitored temperatures (20° - 24°C),
rotation/agitation has continuously occurred and the product has at least 24 hours shelf life remaining
(unless other arrangements have been made). Approval for return must be obtained from the local
Hospital Services management or the Regional Hospital Services Manager.
5. Please list all products being transferred on a Transfer Form supplied by Hospital Services and document the
reason why to ensure proper credit.
NOTE: Any products that have been defaced cannot be transferred or returned for credit.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
Page 6
PACKAGING BLOOD PRODUCTS FOR RETURN/TRANSFER
All blood products must be returned to the Red Cross, or transferred to the receiving hospital, in the same
temperature range in which they are stored. Failure to do so would result in the destruction of what would have
been usable, valuable products. Credit will not be extended for products that are not packed in a manner that
maintains the appropriate temperature range for the duration of the transfer/return.
1.
Red Cells and Whole Blood:
Pack in an insulated box supplied by the Red Cross with units sitting upright and each unit in contact with a
bag of wet ice. Approximately 18 lbs of ice should be adequate to maintain the required 1-10º C temperature
range. Do not stack units on top of each other as units farthest away from the ice will not remain within the
required 1-10ºC.
2.
Platelets:
Platelets should be returned/transferred at room temperature in an insulated platelet container provided by the
ARC. The platelets should be packed with room temperature ”Polar Packs” (“temperature stabilization
packs”) provided by the ARC. Platelets should be packed immediately prior to return so that the time off a
rotator/agitator is minimized. Room-temperature Polar Packs should be in contact with all the units to ensure
the required optimal temperature range.
3.
All units to be returned or transferred should be accompanied by a fully completed Return Authorization
Form or Transfer Form. Whole Blood number, blood type, expiration date, product type and reason for
return/transfer should be filled out, as well as the returning hospital's name, and if applicable, the receiving
hospital's name if applicable.
4.
Additional information requested on the form must be completed by the tech returning/transferring the
products (i.e., time, date, temperature at time of packaging and signature of tech).
a) For returns, keep the appropriate copy for your record and return the other pages to the Red Cross.
b) For transfers, keep the appropriate copy, send the appropriate copy to the receiving hospital with the
products, and send all the remaining pages directly to the Red Cross.
5.
All products should be packed for transport by a blood bank tech or other designated lab staff familiar with
the proper procedures. The appropriate paperwork must accompany all returns to the Red Cross and all
transfers between hospitals.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
Page 7
DELIVERY SCHEDULES
Blood and products transported to and from the ARC or transferred between hospitals are transported by paid or
volunteer staff. Scheduled routine deliveries are made to metropolitan Tulsa, Dallas, Longview, Houston,
Harlingen, Wichita Falls, and Waco hospitals and clinics daily. The hospitals in outlying areas of the Blood
Services region have weekly, twice-weekly or biweekly delivery schedules, according to their transfusion needs.
If you would like to adjust your inventory order or your delivery schedule, please contact the Regional Inventory
Manager.
Deliveries that are requested at non-routine times are dispatched through use of volunteers, overnight courier, or
paid staff. A freight charge to the hospital may accompany these non-routine orders.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
Page 8
RESPONSE TIME
Response time is the interval between the time a blood order is placed with Hospital Services and the time the
requested units are delivered. Response time varies according to many factors.
The primary determinant of response time is the availability of the specific blood components requested. If the
component is routinely manufactured and stocked by Hospital Services, a delivery can be completed more quickly
than if the component is available only as a special request. As deliveries are normally prioritized based on need
(STAT, followed by ASAP, Surgery/To give, Stock and Trade), response time is also affected by other the
requests being made on the available blood supply by other hospitals served.
Obviously, the distance which needs to be traveled in order to complete a delivery is a major factor to consider, as
are existing road, weather, vehicle and traffic conditions which vary according to the route, time of day, time of
week, etc., and the vagaries of nature.
Although a large number of variables still exist that are beyond the Red Cross's control or influence, we have taken
steps to eliminate or reduce the effects of many already mentioned:
1.
The routine production and storage of Leukoreduced Red Blood Cells, Leukoreduced Platelet Concentrates,
Single Donor Platelets, Fresh Frozen Plasma/Frozen Plasma and Cryoprecipitate, make these components
available from Hospital Services at all but the most unusual times. Unfortunately, there are rare aberrations
when clinical usage increases significantly, or conversely, sharp drops in blood collection and/or production
occurs, that may temporarily affect availability of certain products.
2.
The maintenance of adequate levels of blood inventory in each hospital served significantly reduces the
number of true emergency situations that occur. However, during times of critical shortages, the cooperation
of hospitals willing to tolerate a lower inventory level, especially of group O red cells, is invaluable
cooperation with the Red Cross to best manage limited resources
3.
The current courier system in use assures timeliness in service, and will notify us when they are unable to
meet the Red Cross's needs. Any delays in an expected or scheduled delivery time will be conveyed to the
hospital.
4.
However, through appropriate staffing patterns, on-call scheduling, and willing and conscientious volunteers,
there almost always will be a staff member or volunteer immediately available to make an emergency
delivery.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
Page 9
EMERGENCY AND EXCEPTIONAL RELEASE OF BLOOD PRODUCTS
Under extenuating circumstances or in situations in which patient care could be severely compromised, products
may be "emergency” released or “exceptional” released. Both require the approval of the Red Cross Medical
Director, and the ordering physician or the Medical Director of the receiving hospital’s Transfusion Service.
Product(s) will arrive with a label indicating which tests have been completed; at a minimum, the ABO group and
Rh type will have been determined and is indicated on the blood bag label. As the other infectious disease-related
tests are finished, the results will be called to the transfusing facility by the Red Cross.
All efforts will be made to use products from a repeat donor who has donated recently. If any test results are
positive or irregular, the Medical Director of the receiving Transfusion Service can sign the Authorization for
Emergency Release or the Authorization for Exceptional Release form for the ordering physician, and return the
completed form to the ARC. As an option, verbal approvals are acceptable but must be followed up with a
signature on a hard copy, which can be faxed to the American Red Cross.
Emergency Release of Blood Products
1. Blood components that are “emergency released” are shipped to the hospital BEFORE the results of all FDA-
2.
3.
4.
5.
required tests are completed, with the exception of the ABO/Rh of each unit. Emergency-released product(s)
will arrive with a label indicating which tests have been completed, if any. As the other tests are finished, the
ARC will call the results to the transfusing facility.
Should any test result be positive or irregular, the Red Cross Medical Director will contact the recipient's
physician to discuss the potential implications and any available options.
All emergency released products are not returnable for credit.
Granulocyte products are one component type that must always be an “emergency released” product because it
has only a 24 hour shelf life. For granulocytes, the ARC recruits only repeat donors who have donated
recently with acceptable test results.
An “Authorization for Emergency Release” form accompanies each product and must be signed by the
ordering physician or the hospital’s Transfusion Service Medical Director, and returned to the American Red
Cross; this can be done be fax.
Exceptional Release of Blood Products
1. Components that are “exceptional released” are units that have been collected from a donor who has not met
all allogeneic criteria. The donor may have an unacceptable health history or risk behavior, or one or more
known positive test result for an infectious disease, or both. Despite this information, such a donor is still
accepted because the ARC Medical Director, with or without the patient’s physician, has deemed that such a
unit is still desirable.
2. Usually, these cases involve a directed donor who possesses or offers some specific medical benefit desired by
the patient’s physician. This benefit is perceived to outweigh the potential risks to the recipient.
 One example is a mother who has just delivered an infant suspected to have neonatal alloimmune
thrombocytopenia (NAIT). For these cases, the mother’s platelets are the product of choice. The
“exception” in this example is the need to waive the standard donor criterion deferring recently pregnant
women for six weeks.
 Another example is the donor of stem cells transplanted to a patient who is now refractory to platelet
transfusions. At this point, “compatible” platelets would be indicated. Since compatibility has already
been established between the stem cell donor and this patient, the expectation would be that this donor’s
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
Page 10
platelets would result in a higher platelet count in this patient. The “exception” in this example is that the
donor is known to have a positive HBcore antibody, which normally would have disqualified him from
donating allogeneic blood. By using the exceptional release option, this donor’s platelets, desired by the
patient’s physician, can be collected and used.
INVENTORY INFORMATION
Stock inventory levels of red cells by blood group and type are determined by the Regional Inventory Manager
and Hospital Services staff working with customer hospitals. These levels are derived by using transfusion
statistics, operating room activity, distance from the distributing center, hospital size and services, and availability
of products. Inventory levels are adjusted as needs change and as availability fluctuates. Storage must be in a
monitored refrigerator maintaining temperature at 1-6o C.
Platelets are usually not a stock inventory item since their shelf life is so short (5 days from date drawn). Platelets
should only be ordered when use is expected, unless a one-way standing order has previously been established.
Red cell inventory should include all units (crossmatched and uncrossmatched) in inventory by blood type are
determined by the Regional Inventory Manager and Hospital Services working with the customer hospitals. These
levels are derived by using transfusion statistics, extent of operating room activity, distance from the blood center,
hospital size, and availability of products. Inventory levels are adjusted as needs change and as availability
fluctuates. Storage must be in a monitored refrigerator set at 1-6o C.
Inventory levels of frozen plasma and cryoprecipitate is decided by the individual hospital and should be based
on monthly usage. Units shipped usually have at least a six month shelf life. Storage must be in a monitored
freezer set at ≤-18°C.
Each weekday morning, a representative of Hospital Services will phone each hospital transfusion service to
obtain its red cell inventory and transfusion data. Red cell inventory includes all units (crossmatched and
uncrossmatched), listed by blood group and type as of midnight of that day. Directed and autologous units are to
be reported by the total number in inventory; break down by group and type is not required. Also, at this time,
please report any platelets that are being held and any short-dated red cells (metropolitan hospitals only). This will
enable us to prevent the outdating of units when usage is anticipated. Local hospitals will be told what short-dated
blood types are available in town, so that "to give" orders can be filled with these products at no extra expense to
the patient. Cooperation from all hospitals, working closely with Hospital Services, will mean good stewardship
of the blood supply.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
REFERENCE LABORATORY
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
REFERENCE LAB
Page 1
REFERENCE LABORATORY
I.
II.
Hours of Operation & Phone Numbers
A.
Oklahoma customers:
1.
During normal business hours, contact the Reference Laboratory at the Tulsa Location:
Monday – Friday, 8:00 AM to 5:00 PM:
(918) 831-1131
Fax:
(918) 831-1628
2.
After hours, and on weekends and holidays, contact Hospital Services:
(918) 831-1115 or 800-722-5971
B.
Southwest Region has partnered with contract laboratories in the state of Texas to provide basic
Reference services for Texas customers. Customers should contact their local Southwest Region
Hospital Services Department or the Tulsa Reference Laboratory to request Reference Laboratory
services. Calls will be routed to the appropriate Reference Laboratory. More advanced reference
samples will be forwarded to the Reference Laboratory in Tulsa, Oklahoma as needed.
C.
Twenty-four hour “on call” coverage is maintained for off-hour emergency cases, seven days a week.
A surcharge will be assessed for Reference Laboratory services provided on weekends, holidays,
and after hours.
Specimen Referral Guidelines
A.
Reference services are available to regional hospitals and clinics for resolution of red blood cell
serological problems and pre-transfusion testing. Crossmatched platelet components are also available
from the Tulsa Location Reference Laboratory. Samples requiring platelet or granulocyte antibody
testing or identification are sent to the appropriate ARC laboratory, as needed.
B.
Please contact the Reference Laboratory prior to sending a specimen. Telephone consultation
provides invaluable case information and assists Reference Laboratory staff in expediting testing and
resolution. Please be prepared to discuss the following details of your case; you can also fax relevant
documents to 918-831-1628.
NOTE: Complete your testing through 37oC and antiglobulin phases before contacting the
Reference Laboratory.
1.
The serological problem—describe as briefly and as specifically as possible. For example:
 Is it an ABO discrepancy?
 a transfusion reaction?
 an alloantibody?
 a possible hemolytic disease of the newborn?
 a positive direct antiglobulin test?
2.
Know the patient’s pertinent history. For example:
 Has the patient ever been pregnant or transfused? How many times and how recently?
 What is the diagnosis?
 Any known history of blood-related problems?
 What is the patient’s age and race?
 What drugs are currently being administered, as well as those recently discontinued?
 What is the patient's current hematocrit value or platelet count?
3.
Discuss your serologic test results. For example:
 What is the patient’s ABO group and Rh type?
MW: MANUAL: 2292_1
PD:02/05/16, Administration

How strong were the reactions?
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
REFERENCE LAB
Page 2


What were the auto control and/or direct antiglobulin test result?
At what phase of testing and with what type of enhancement medium did you encounter
the problem?
NOTE: Serologic reactions with Screening Cells seen only at Room Temperature or
Immediate Spin phases of testing are generally considered to be not clinically
significant.
C.
The sample must be sent with a completed Reference and Consultation Request form (see
Attachments). The form must be complete. Requests will be rejected if samples are not
properly labeled or if there is a paperwork discrepancy.
1.
Indicate the name of the requesting hospital and include a telephone number with an area
code. Also, provide the name of a contact person that the ARC Reference Laboratory
Technologist can call to discuss the case (Section A of the Reference and Consultation
Request form).
2.
Complete all patient information (Section B of the Reference and Consultation Request
form). Please make every effort to provide all requested information in this section.
(a)
The patient's complete name, hospital identification number, Social Security Number
and date of birth are used to link the patient with previous testing records. Race,
diagnosis, Hgb/Hct values, pregnancy and medication histories assist in evaluating
current serologic discrepancies. Transfusion dates should be included, especially if
within the previous three months. This information is necessary to obtain accurate
antigen typing results for the patient.
(b)
It may be necessary to obtain this information directly from the patient or the patient's
family members if not available in the hospital record.
3.
Indicate the serological problem encountered (Section C of the Reference and Consultation
Request form). Include the results of all serological testing done at your facility and any
blood group antibodies previously identified for the patient (Section D of the Reference and
Consultation Request form). Please include a copy of any panels or other serologic work
performed on the current patient sample.
4.
State the number and type of components required and indicate if they need to be
crossmatched, antigen negative, leukoreduced and/or irradiated. Indicate the date/time of
intended transfusion. If components are on hold, provide date/time of intended surgery or
other procedure, as necessary. The requesting physicians name must be documented if
crossmatched components have been ordered. (Section E of the Reference and Consultation
Request form).
NOTE: Once an order for irradiated components for a patient is received by the
Southwest Region Reference Laboratory, all subsequent orders for this patient
will be filled with irradiated components, unless changed by the patient's
physician and/or the ARC Medical Director.
5.
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Ensure that the patient specimen meets stated guidelines (see Section III). The Southwest
Region Reference Laboratory complies with the American Association of Blood Banks
Standards. Incorrectly or incompletely labeled specimens will not be used for
compatibility testing.
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
REFERENCE LAB
Page 3
NOTE: The Identification Number documented on the Reference and Consultation Request
form MUST correspond to the Identification Number on the sample test tubes. The
identification number utilized should be the number that will be used to identify the
patient at the time of transfusion, and may be the Hospital Number, Medical Record
Number, Social Security Number or a manufactured Blood Bank bracelet number.
III.
Specimen Collection Requirements
A.
Collect at least 7 ml of blood in an EDTA tube. All specimens should be < 72 hours old.
NOTE: Do not use serum separator tubes.
II.
B.
All tubes must be labeled legibly with the patient’s full name, identification number, date and time
drawn, and initials of the phlebotomist.
C.
If compatible units have been identified at the hospital, send appropriately labeled segments.
D.
Other samples, such as Cord Blood, Pre- and Post-Transfusion samples and/ or segments from
previously transfused units, may be requested when indicated.
Transportation
The Southwest Region will pick up samples referred to its Reference Laboratory. The Reference
Laboratory technologist will work together with the hospital technologist to determine appropriate time
frame and transportation method for sample pickup.
III.
Reporting Results
A.
Reference Laboratory staff will call the hospital as soon as the work on the sample is completed to
give a verbal report of preliminary findings.
B.
A preliminary report will be sent to the hospital via FAX and a final report via mail for its records.
Reports will include patient information, testing results and transfusion recommendations.
NOTE: Please be aware that the final report sent may differ from the information that was given in the
preliminary report. An infrequent occurrence, the change is usually not significant and with
negligible, if any, effect on patient care. Should there ever be a discovery that might have
adverse effect on patient care, you will be immediately alerted by telephone.
C.
For crossmatched components, compatibility tags will be completed with patient information, unit
information and crossmatch results.
1.
If the patient has a warm autoantibody or an HTLA antibody, the crossmatch results may
indicate that only incompatible units are available. However, such units are satisfactory for
transfusion.
2.
Any adverse reaction must be reported to the Southwest Region Reference Laboratory and the
patient's attending physician immediately.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
REFERENCE LAB
Page 4
IV.
Contract Transfusion Service
The Reference Laboratory also performs routine pretransfusion testing and crossmatches for those
clients who have contracted with the ARC to act as their Transfusion Service. Both the Blood Services
Agreement and the Transfusion Services Agreement specify that the client will have appropriate
standard operating procedures and specific insurance requirements, as well as a quality assurance
program.
V.
VI.
Component Selection
A.
An inventory of pre-screened LRBCs known to be negative for a variety of common antigens is
maintained at the Tulsa and Dallas locations. The specific antigen types vary due to current donor
availability, but historical ordering patterns are used to recruit eligible donors who have the most
frequently requested antigen types.
B.
We recommend transfusion of crossmatch-compatible RBC components for patients with certain
antibodies usually considered clinically insignificant regardless of serologic test results. Accordingly,
RBC components that are negative for M, N, P1, Lea and/or Leb are not provided on a routine basis.
C.
Licensed antisera to low frequency antigens is not readily available, therefore, we recommend
crossmatch compatible red cells for transfusion if antibodies directed towards low frequency
antigens are detected.
Rare Donor Blood
A.
B.
The Reference Laboratory screens Group O donor samples to identify those donors with useful
combinations of common antigens and donors who are negative for high incidence antigens.
1.
This information is entered into the donor’s record, allowing ARC to identify these donors on
subsequent donations and to recruit donors of a needed antigen type if necessary.
2.
Names of donors with rare blood types are submitted to the American Rare Donor Program to
become part of a large pool of donors that can be utilized for patients throughout the United
States, and occasionally, even in other countries around the world. In turn, this pool of
donors is available to us in case we are unable to locate the needed antigen type in the
Southwest Region.
Frozen inventory of RBCs that are negative for high incidence antigens or certain combinations of
common antigens is maintained by the Tulsa Location Reference Laboratory.
1.
2.
3.
C.
These units can be thawed and deglycerolized at the Tulsa Location or shipped frozen to other
locations as needed. Once thawed and deglycerolized, the expiration date of these
components is 24 hours.
Due to the rarity of these components and the very short expiration time, a definite “to give”
order for transfusion must be provided prior to the thawing and deglycerolization process, and
the medical indication for transfusion must be appropriate.
Consultation with the ARC Medical Director may be needed before units are thawed.
Requests for RBC components that are negative for multiple antigens or high frequency antigens
may be filled from our frozen inventory or components may be obtained through the American
Rare Donor Program.
MW: MANUAL: 2292_1
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American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
REFERENCE LAB
Page 5
1.
Such components require additional time to prepare and/or obtain. Requesting hospitals will
be notified of time frames before these sources are utilized.
2.
If the RBC phenotype requested meets Rare Donor requirements, the Tulsa Reference
Laboratory must first confirm the identity of the antibody(ies) before any attempt is made to
secure requested components.
MW: MANUAL: 2292_1
PD:02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
REFERENCE LAB
Page 6
TESTING
LABORATORIES
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American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
TESTING LABORATORIES
Page 1
National Testing Laboratories
Five National Testing Laboratories (NTLs) comprise the only nationwide network of laboratories dedicated to
donor blood testing. Strategically located throughout the country, these five state-of-the-art laboratories offer highquality testing and stringent in-process controls. The Red Cross has over fifty years of donor blood testing
experience and tests over six million donations annually.
The National Testing Laboratories are FDA licensed, AABB accredited and CLIA certified. The National
Testing Laboratories must also maintain compliance with state requirements. The NTLs maintain a rigorous
cGMP laboratory environment and process control. Comprehensive Quality Assurance and Quality Control
programs govern all five standardized Red Cross testing facilities. Contingency and emergency back up
testing capacity ensures that essential services are provided without interruption.
The Southwest Region daily submits donor sample tubes for testing to the National Testing Laboratory located in
St. Louis, Missouri. Shipments are scheduled twice daily and are categorized as priority, to expedite testing of
platelet components and special collections, or as routine. “STAT” testing is not available.
Please note that other factors such as weather, work stoppages, air flight schedules, etc., may cause the region to
divert tubes to one of the other ARC National Testing Labs. Since prompt turnaround time is the primary concern
of the American Red Cross, this diversion usually has only a minor effect on the availability of blood.
Confirmatory Laboratory
The Confirmatory Laboratory (CL) located in Charlotte, NC, is one of the country’s most prominent laboratories
for infectious disease confirmatory/supplemental testing. The Confirmatory Laboratory is innovative in
establishing new algorithms for confirmatory testing, working in partnership with the American Association of
Blood Banks and the scientific community. Performing rigorous high-quality tests using FDA approved testing
algorithms, the Confirmatory Laboratory produces reliable results under strict regulatory standards and adherence
to current Good Manufacturing Practices (cGMP). All FDA, CLIA and other licensing requirements are fully
satisfied.
National Genome Testing Laboratories
National Genome Testing Laboratories (NGTLs) are co-located with each of the five NTLs of the ARCBS system.
These NGTLs only perform nucleic acid testing (NAT). NAT employs testing technology that directly detects
the genetic material of various infectious (viral) agents. Its methodology uses a process called “transcription
mediated amplification” (TMA) that was developed by Gen-Probe, Inc. The Southwest Region submits donor
sample tubes daily for NAT by the NGTL located in St. Louis, Missouri. Shipments are scheduled twice daily and
are categorized as priority or routine in the same manner as for NTL testing. “STAT” testing is also not available.
Initially performed as an investigational trial, NAT for HCV and HIV are being done using FDA licensed tests as
of early 2003. Once this type of testing occurred, HIV-Ag testing was discontinued per current FDA
requirements.
As of early July 2003, an NAT method for detecting West Nile Virus (WNV) was initiated under an
Investigational New Drug (IND) application. This test is being performed on donor samples in minipools year-
MW: MANUAL: 2292_1
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American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
TESTING LABORATORIES
Page 2
round. The NGTL in St. Louis, Missouri, can switch to individual donor testing if warranted. This switch will
occur when the frequency of positive samples reach/exceed a set level as recommended by the AABB.
In June 2004, new investigational NATs, also under IND applications, were initiated for HBV, HAV and
parvovirus B19. These tests are performed on only certain donor samples that meet the IND protocols. Additional
investigative NAT methodologies for other infectious diseases, such as Chagas’ disease, are anticipated in the
future.
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American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
QUALITY CONTROL
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American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
QUALITY CONTROL
Page 1
QUALITY CONTROL
I.
Quality Control of Blood Components
Southwest Region’s blood component quality control (QC) requirements are established by the
American Red Cross Blood Services, and are compliant with current American Association of Blood
Bank Standards and all FDA requirements, as summarized below:
Requirement
Acceptable
Pass Rate
HCT < 80%
100%
Residual WBC < 5 x 106
Red Cell Recovery > 85 %
100%
100%
> 50 g Hemoglobin
95%
RBC recovery > 80 %
Initial Wash < 1000 mg %
Hemoglobin
Final Wash < 160 mg %
Hemoglobin
100%
All components
> 1.0 x 1010 granulocytes
75%
Random
75% of total
production, or,
40 components
> 5.5 x 1010 platelets
pH > 6.2 (at end of storage)
Volume: 40-70 mL
Color: light straw to light pink
Residual WBC < 5 x 105
90%
100%
100%
100%
100%
> 3.0 x 1011 platelets
90%
Apheresis
4 units
(minimum) per
each variable:
 collection
facility
 component
type
 machine type
 collection
chamber
Component/Type
Non-additive
Leukoreduced
(LR)
Red
Blood
Cells
Apheresis,
LR
Deglycerolize
d
Granulocytes (by
apheresis)
Platelets
LR
Cryoprecipitate
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PD: 02/05/16, Administration
Minimum
Sample Size per
Month
4 units per
anticoagulant
type
1% of total
production
50 components
per collection
facility
4 components
4 components
pH > 6.2
Color: light straw to light pink
100%
100%
100%
100%
Residual WBC < 5 x 106
100%
Factor VIII averages > 80 IU
Fibrinogen averages > 150 mg
n/a
n/a
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
QUALITY CONTROL
Page 2
II.
Quality Control of Shipping Containers
A.
B.
III.
All shipping containers utilized by the American Red Cross for the transport of blood and blood
components have been validated to ensure maintenance of required shipping temperature ranges.
Quality control shipping checks are performed semi-annually to evaluate compliance with
shipping protocols and to evaluate the performance of the shipping containers on a regional
basis.
Recalls and Market Withdrawals
Occasionally, blood or blood component(s), which have been shipped to a customer, must be returned to the
American Red Cross. The retrieval of blood and blood components is to ensure that products which are
available for transfusion meet all criteria for safety, quality, identity, purity and potency (SQuIPP).
A.
Process
1.
2.
3.
4.
B.
Recalls and market withdrawals of in-dated blood and blood components will be initiated by
Red Cross staff via a telephone call to the customer.
(a) For outdated components, a notification generally will be faxed. If timelines are short,
notification by phone may occur. Implicated components may date back several years,
depending on the reason for the retrieval action.
(b) Phone notifications are followed by a faxed letter within 10 days.
The customer may be requested to immediately quarantine the blood or blood components
until they can be returned, or simply to discard the unit(s).
Red Cross staff will coordinate transportation arrangements for the return of blood and blood
components.
For outdated components, the disposition of these products will be requested. This
information can be recorded on the recall or market withdrawal letter from the American Red
Cross and returned by mail or fax. See next section.
Follow-up Requirements
1.
2.
3.
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PD: 02/05/16, Administration
With each recall or market withdrawal notification, the consignee is asked to indicate the
disposition of the involved component(s).
(a) For outdated components, this could be “discarded,” “transfused,” or “transferred.” For
units that are “transferred," please include the name and location to which the
component was transferred.
(b) For indated components, disposition could be any of the ones mentioned for outdated
units, plus “returned”—which would have been at the request of the Red Cross.
Return the completed form to the American Red Cross by facsimile or in the enclosed selfaddressed, postage paid envelope (if mailed) as soon as possible. If the ARC does not receive
a response within 30 days, a follow-up notification will be sent.
If the component has been transfused, any further action, such as recipient notification, is to
be determined by the facility’s Medical Director or designee, or by following a specific
facility policy. The Southwest Region’s Medical Director is available for consultation. Also
refer to the next section.
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
POST-TRANSFUSION
RECIPIENT MANAGEMENT
Post-Transfusion Recipient Management
Page 1
POSSIBLE RECIPIENT TRANSFUSION-TRANSMITTED INFECTION (PRTTI)
I.
Purpose
Regulations and standards of the American Red Cross (ARC) require investigation and reporting of all
possible cases of transfusion-transmitted infection. The Code of Federal Regulations (CFR), Title 21,
Section 606.170 (a), requires blood collecting facilities to investigate reported occurrences of Possible
Recipient Transfusion-Transmitted Infection (PRTTI), formerly called “Suspected Post-Transfusion
Infection” (SPTI) by the ARC.
To comply with federal regulations, the Red Cross relies on transfusion facilities to report all possible
transfusion transmitted infections such as HIV, HTLV, HBV and HCV. The ARC also should be notified
of other, less common infectious diseases that are known to be transfusion transmitted, such as Babesiosis or
Chagas disease, or West Nile Virus.
II.
Responsibilities of Transfusion Facilities
A.
Complete the appropriate sections of a PRTTI Case Notification form for any possible transfusion
transmitted infection and mail or fax to:
Case Investigator (CI)
American Red Cross Blood Services - Southwest Region
10151 E. 11th Street
Tulsa, OK 74128
Fax: 918-831-1663
B.
Annually, the ARC sends to all hospital customers the current versions of the forms to be utilized for
reporting possible transfusion-transmitted infections and transfusion reactions; additional copies can
be made by photocopying these forms. For forms and/or information, please call the CI at 918-8311101 or 1-866-210-5495.
C.
Submit as much information as possible on the recipient, including all related test results and the
Whole Blood Numbers of all possibly involved units transfused. The name of the recipient is not
necessary, however, a unique identifier that links to the recipient must be included.
ALL INFORMATION WILL BE MANAGED CONFIDENTIALLY.
III.
ARC Case Investigation
A.
Only cases with sufficient documentation (as provided by the reporting transfusion service) will be
evaluated to determine if opening a case investigation is warranted. The American Red Cross Medical
Director/designee may call the hospital for additional information in order to make this determination.
The Medical Director will take into consideration the following information:
1. Clinical presentation and findings consistent with suspected infectious disease
2. Other confounding factors, such as other known risk factors (including prior blood transfusions),
or prior/past history of a diagnosis for the infectious disease suspected to be transfusion
transmitted
3. Pre- and post-transfusion laboratory tests, especially those with a confirmatory test result
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American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Post-Transfusion Recipient Management
Page 1
4. On the donors’ side, any donation history, especially non-reactive test results, that clearly exclude
the donor(s) as the infected source
B.
IV.
For a case that is opened and an investigation initiated, the following may occur:
1. Any donor who does not have a subsequent donation with acceptable test results at least 12
months (or other appropriate interval for the specific infection under consideration) after the
involved donation will be contacted and a blood sample requested for follow up testing. Every
attempt will be made to contact the donor for this follow up testing.
2. Donors who are found to be reactive upon re-testing will be managed appropriately. This may
mean deferring the donor or placing the donor “under surveillance.” The latter designation
allows the Red Cross to identify a donor who might be involved in another PRTTI case for the
same infectious disease, and to appropriately defer that donor.
3. Donors lost to follow up (not re-tested or not successfully contacted) will be managed
appropriately, dependent on the validity of the reported case and other findings from the case
investigation. These donors may be left as eligible, or be placed “under surveillance.”
4. The ARC no longer limits investigation to cases with ten or fewer components involved. Case
investigation is initiated based on the merits of the information received and the likelihood that
the reported disease could have been transfusion-transmitted.
Case Investigation Summary
A.
B.
When all involved donors have been investigated, a letter summarizing the findings will be sent to the
reporting facility’s Medical Director and/or Blood Bank Supervisor within 10 working days following
review and closure by the American Red Cross Medical Director.
If the summary indicates that transfusion transmission is not the explanation for the recipient’s
infectious disease, the ARC can consider a re-investigation of the case should the transfusion facility
discover additional, more compelling information supportive of transfusion transmission.
.
POSSIBLE TRANSFUSION REACTION CASE REPORTS
I.
Purpose
The ARC must investigate all reports of possible transfusion reactions when it is decided by the transfusing
facility that the component is suspected to be at fault in causing the reaction. Some examples include:



II.
Bacterial contamination or sepsis
Transfusion-related Acute Lung Injury or “TRALI”
Transfusion-associated Graft versus Host Disease (TA-GVHD) when recipient is supposedly
receiving only irradiated blood components
Responsibilities of Clinical Service and Transfusion Service
A.
Each year, the ARC sends to all hospital customers the current versions of forms for reporting
possible adverse recipient reactions and transfusion-transmitted infections. Additional copies can be
made by photocopying the forms. For any questions about the forms and/or information, please call
Donor Management at 918-831-1101 or 1-866-210-5495.
B.
Submit as much information as possible regarding the recipient and the adverse reaction. Note that
the Possible Transfusion Reaction Case Report form has been revised. It still is divided into two
sections: Section I –Clinical Information, and Section II – Transfusion Service.
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American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Post-Transfusion Recipient Management
Page 1
1.
ALL INFORMATION WILL BE MANAGED CONFIDENTIALLY.
(a)
The name of the recipient is not necessary; however a unique identifier that links to the
recipient must be included. Other patient demographics may be useful information, such
as age and sex of patient, etc..
(b)
In Section I, please include all related clinical signs and symptoms, timelines, underlying
or co-existing medical condition(s), other possible co-existing causes of the patient’s
clinical status, and pertinent lab or other test results, such as chest X-ray findings, SwanGanz catheter readings, etc..
(c)
In Section II, please include the serologic findings on pre- and post-transfusion
specimens (“post-reaction work-up”) and all other post-transfusion tests ordered, with
results, if known. These other tests might include bacterial cultures on product(s) and
patient, HLA typing and/or HLA antibody screening, etc., relevant to the suspected
transfusion reaction.
2.
After completion of sections I and II of the Recipient Adverse Reaction Form, mail or fax to:
Case Investigator
Donor Management Department
American Red Cross Blood Services - Southwest Region
10151 E. 11th Street
Tulsa, OK 74128
FAX: 918-831-1663
LOOKBACK PROGRAM
I.
Purpose
The Lookback process was mandated by the Food and Drug Administration once testing for HIV, HTLV,
and then HCV, were licensed for blood donor screening. As these tests were implemented, the FDA
realized that donors, now identified to be infected, could have prior donations that might have infected any
number of recipients. “Lookback” was conceived to identify and inform these potential victims. The
process involves the blood center to notify the consignees (transfusing facilities) of possibly infected
components. Once notified, these transfusing entities identify the recipients and then notify the recipients’
physicians. The goal is to inform recipients who might be infected, who might not know of this risk, and
thus to be tested for HIV, HTLV, or HCV.
II.
Procedure
A.
The American Red Cross (ARC), upon receiving confirmed positive test results, or notification from
another confirmed source will:
1.
Determine if the donor has any prior donations. If found, an immediate stock recovery and
market withdrawal of all potentially affected components will be initiated on all donations
within the required time frame.
2.
Send a letter notifying the Medical Director or Blood Bank Supervisor of the transfusion facility
that a lookback has been initiated and requesting the completion and return of an attached
Recipient Status form. If the completed form is not returned to ARC within 60 days, a followup notification will be sent.
MW: MANUAL: 2292_1
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American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Post-Transfusion Recipient Management
Page 1
B.
Upon receipt of the written notification, the hospital/transfusion facility is responsible for recipient
notification. Though this is usually accomplished via the involved patient’s physician, patient notification
is ultimately the responsibility of the transfusion facility.
C.
If the recipient’s physician determines that follow-up testing for the recipient should be performed by
ARC, contact the Case Investigator (CI) at 918-831-1101 or 1-866-210-5495. Testing will be performed
at no charge to the recipient.
MW: MANUAL: 2292_1
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American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
QUALITY ASSURANCE
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PD: 02/05/16, Administration
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
AMERICAN RED CROSS BLOOD SERVICES, SOUTHWEST REGION
QUALITY ASSURANCE PROGRAM
I.
QUALITY ASSURANCE (QA) STRUCTURE
A.
Quality Assurance was created as an American Red Cross Biomedical Services department/program
in 1994 to function and report independently of the operational/manufacturing units of Biomedical
Services.
B.
The organizational structure of the QA department parallels that of the operational/manufacturing
sections and departments.
1.
2.
C.
Current staff in the Southwest Region
1.
2.
3.
4.
5.
II.
Regional Quality Director (RQD) reports to Division QA Director
[parallels Regional CEO reports to Division Vice President (VP)]
Division QA Director reports to Biomedical Headquarters (BHQ) Vice-President of Quality
Assurance/Regulatory Affairs
(parallels Division VP reports to BHQ Executive Vice-President/COO and Responsible
Head).
Regional Quality Director
Two Quality Managers
One Quality Senior Associate
Two Quality Associates
Two Quality Specialists
QUALITY ASSURANCE DEPARTMENT RESPONSIBILITIES
A.
Standardized American Red Cross Biomedical Services procedures are used throughout all blood
collecting regions of the American Red Cross. Compliance with all such procedures as well as
all applicable federal and state regulations is ensured by QA staff performing the following
activities and functions:
1.
2.
3.
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PD: 02/05/16, Administration
Review and approve the following documents, developed at both BHQ and in the region,
prior to implementation:
a.
Procedures
b.
Training plans
c.
Equipment validation plans
d.
Information systems development and validation plans
e.
Advertising and promotional material
f.
Pilot and operational trials’ protocols
Review and approve the results of equipment and computer system validations prior to
the equipment or software being released for use.
Periodic reviews of the following records:
a.
Manufacturing process records
b.
Recipient Lookback records
c.
Possible Recipient Transfusion-Transmitted Infection (PRTTI) records
d.
Donor Deferral Register (DDR) records
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
4.
B.
III.
Walk-through visits and procedure verifications to further ensure compliance:
1.
Quality Assurance staff perform frequent walk-through visits of various operations
throughout the region, including Collections, Manufacturing, Distribution and support
departments to verify that procedures are being followed as written and to answer any
questions that staff members might have.
2.
Quality Assurance staff perform verifications of procedure changes as directed by BHQ.
As procedures change throughout the region, the QA staff visit the departments to verify
that the changes are understood and implemented as directed, typically at 30-days post
implementation as well as 90-days post implementation.
REPORTS of RECORD REVIEWS, AUDITS, and VERIFICATIONS
A.
All reports of record reviews, deviation trend analysis, walk-through visits and verifications are
provided to the regional Chief Executive Officer, Medical Director, and the department head of
the manufacturing section involved.
B.
All reports are also submitted to the American Red Cross Biomedical Services’ South Central
Division Office.
C.
Deviation tracking/trending reports are submitted to the Division Office and Biomedical
Headquarters for tracking and trending reports on division and national levels.
D.
Report availability to external inspectors/auditors
1.
2.
IV.
e.
Donor information records
f.
Training records
g.
Customer complaint records
Monitoring and managing deviations from standardized manufacturing procedures:
a.
Review deviation reports
b.
Report Biological Product Deviations (formerly referred to as errors/accidents) to
the Food and Drug Administration
c.
Monitor deviations for trends
d.
Monitor effectiveness of corrective actions implemented
e.
Oversee Material Review Board (MRB) process to determine product disposition
or need for recall/market withdrawal actions
f.
Suspend manufacturing activities if a deviation affects critical control processes
possibly adversely affecting product safety, quality, identity, purity or potency
(SQuIPP) or donor safety.
g.
Identify, report, and track potential system problems.
Schedules and dates of completion are available to external inspectors/auditors on request.
Contents of reports remain confidential and proprietary during other external audits in
order to ensure that potential problems continue to be reported so that corrective actions
can be implemented and monitored for effectiveness.
REGULATORY COMPLIANCE AND QUALITY AUDITS (RCQA)
A.
Performed by American Red Cross Biomedical Services staff of the National Regulatory
Compliance and Quality Audits department.
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V.
VI.
B.
Audits occur annually and are system-based.
C.
Corrective action plans to address system deficiencies must be approved by the RCQA lead
auditor.
D.
Corrective action implementation must occur prior to closure of the system deficiency finding
and the external audit.
E.
Regional Quality Assurance staff monitor the effectiveness of corrective actions implemented.
OTHER EXTERNAL INSPECTIONS
A.
Food and Drug Administration (FDA)
1.
FDA inspections currently occur annually.
2.
Written responses to all observations listed on the FDA Form 483 are submitted to the
FDA District Office.
3.
Corrective action is also implemented to address any comments made by the FDA
investigator during the closing session concerning the state of control in manufacturing or
clinical services’ operations and processes.
4.
Regional QA staff monitor the implementation and effectiveness of the corrective actions
taken in response to all FDA Form 483 observations and FDA investigator comments.
B.
American Association of Blood Banks/CLIA accreditation
1.
The Southwest Region maintains accreditation by the American Association of Blood
Banks (AABB).
2.
The assessment process to maintain CLIA accreditation is included in the AABB
assessment program and is performed by the AABB assessment team.
3.
AABB/CLIA accreditation assessments occur every two years.
4.
Manufacturing processes, clinical services, and quality assurance are evaluated during the
assessment process.
5.
The Southwest Region CLIA accreditation numbers are 37D0474123 for Tulsa and
45D0659989 for Dallas.
PROFICIENCY TESTING PROGRAMS
A.
College of American Pathologists’ (CAP) Proficiency Testing Programs involve Quality Control
and Reference Lab staff of the Southwest Region.
1.
B.
The Southwest Region participates in the following CAP programs:
a. Comprehensive Transfusion Medicine
b. Basic Hematology
c. DAT
d. Transfusion-related Cell Counting
e. Platelet Crossmatching (investigational use only at this time)
American Red Cross/American Association of Blood Banks Proficiency Testing Program
involves the Reference Laboratory staff; samples are received three times/year.
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C.
All results for these proficiency testing programs are monitored by regional senior management
staff, including the Medical Director and Quality Assurance staff.
D.
Root cause analysis and development of corrective action is performed for all proficiency test
failures.
E.
Effectiveness of corrective action is monitored by both operations and QA staff.
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APHERESIS SERVICES
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APHERESIS SERVICES
I.
DEFINITION
The term "Apheresis" is a Greek word meaning to “separate,” to "take out of." Hemapheresis is the
process of collecting freshly drawn blood and separating it into its various constituents. The term
"apheresis" is more commonly used when referring to a number of technical procedures in which a donor’s
blood is collected and processed to allow removal of a specific blood component. The remaining blood is
returned to the donor. A prefix is added to the term "pheresis" to indicate the particular blood component(s)
removed (such as plasmapheresis of plasma, leukapheresis of white cells, or plateletpheresis of platelets).
II.
GENERAL INFORMATION
A.
Apheresis collections are by appointment only. Not all apheresis collection centers offer the entire
range of products or services available within the Southwest Region. Call your local center for its
hours of operation and further information.
B.
Standing orders for apheresis products are accepted. These orders can be temporary, e.g., for a given
patient needing one product biweekly for three weeks, or may be stock inventory.
C.
Special Orders
1. Certain apheresis products are not collected routinely but only when a specific “to give” order is
received. These include HLA-matched platelets and granulocytes.
2. A minimum of approximately 36-48 hours is needed to contact necessary personnel, to recruit a
donor, to collect the product, to complete all required testing, and to transport the products to the
hospital. Refer to the following example:
(a)
Day zero: order is received for granulocytes. A suitable donor must first be called and
an appointment made. If the donor can come to the center and donate on that same day,
then the collection day is also day zero.
(b)
Day one: however, if the donor can only come in on the day after the order is initially
received, the day of collection is now day one. Specimens are sent to the NTL later on
the day of collection as “priority” samples.
(c)
Day two: test results are usually received mid-morning and collected unit is then labeled
by the early afternoon and shipped out.
3. The hospital will be charged for any specially ordered product that is canceled after the
procedure is started and outdates, unless waiver of this charge is approved by the Regional
Hospital Services Manager. For example:
(a)
Granulocytes with a 24-hour shelf-life outdates because patient died; hospital would be
charged the usual processing fee for Granulocytes. However, if collection is aborted
because hospital informs SWR of death prior to completion of collection, the fee may be
for only a portion of the usual total processing fee.
(b)
In contrast, apheresis platelets ordered as HLA-matched for specific patient is not
needed; no charges billed to ordering hospital because collected product is shipped to
and used by another hospital.
4. For the rare situation in which an apheresis product other than Granulocytes is needed “stat,” an
order from the recipient's physician and approval of the American Red Cross Medical Director
or physician on call are required and the emergency release protocol will be followed. An
additional "stat" fee may be charged.
5. All prospective apheresis donors must be interviewed by an apheresis staff person and then an
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6.
7.
8.
III.
IV.
appointment will be made as warranted.
Any requests which do not fall within guidelines for transfusion must be approved by the
American Red Cross Medical Director or designee.
Please call Hospital Services immediately if there is any change in an order or in the condition
of the patient.
For changes regarding HLA-matched platelets, leukopheresis or therapeutic apheresis orders contact the Hemapheresis department as soon as possible. During “off-hours,” call Hospital
Services (See Telephone Directory, Page ii).
SPECIFIC PRODUCTS (also refer to sections on individual component types under “Blood Products”;
for Therapeutic Apheresis services, see later section)
A.
Plateletpheresis: donor time on machine 1-1/2 to 2 hours - 5 day shelf-life.
B.
Plasmapheresis: donor time on machine 30 minutes to 1 hour; approximately 500 mls FFP.
C.
Granulocytes: Donors must be premedicated a minimum of 12 hours before collection with a
corticosteroid (e.g., Prednisone). Collection is usually performed with the addition of
hydroxyethylstarch (HES), a sedimenting agent that increases the number of granulocytes collected.
D.
Red cells: recently modified versions of apheresis equipment allows collection of red cells either as a
“double” unit collection, roughly equivalent to two WB-derived PRBC units, or as a concurrent
collection of one red cell unit with either a unit of plasma and/or platelets also collected. All products
collected are leukocyte-reduced. Donors of “double” red cell units must meet more limited criteria in
regards to hematocrit and total body wait. These donors must wait 16 weeks between this type of
donations.
GUIDELINES for ORDERING and USING APHERESIS PRODUCTS
A.
Platelet Pheresis Products (e.g., Single Donor Platelets)
1. INDICATIONS: refer to earlier section on Blood Products.
2. INFORMATION FOR THE LABORATORY:
(a)
Preferably, should be ABO compatible with intended recipient.
(b)
Product will outdate in 5 days unless otherwise specified. If the product container is
entered for any reason, the dating period for the product must be reduced to 4 hours from
the time of entry.
(c)
Total platelet count meets current AABB standards unless otherwise specified; the actual
platelet count is available upon request. For leukocyte-depleted products, the WBC meets
current AABB standards.
(d)
Continuous, gentle agitation of the platelets at 20-24º C (72ºF) should be maintained.
Platelets should not be refrigerated.
NOTE: As of March 1, 2004, the ARCBS began performing bacterial detection on all apheresis
platelets. This new requirement was introduced in the 22nd Edition of the AABB’s
Standards. Since this testing is considered a QC check, units can be released without
having a final negative result. However, since incubation goes until the end of the expiration
date, a unit might already have been transfused before the bacterial screening turns positive.
For post-transfusion notification of a positive culture result, each hospital transfusion
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service should have a procedure/policy in place for the management of this not unlikely
event.
3. INFORMATION FOR NURSING:
(a)
Standard transfusion filters or the shorter chambered platelet filters are perfectly
acceptable. Never use a microaggregate filter. The use of a bedside leukocyte reducing
filter is not needed and might reduce the potency of the unit by reducing that number of
platelets.
(b)
Observation of patient may be the same as with standard transfusions. If the patient
shows no reaction, a standard transfusion rate may be used.
(c)
Please call the Hospital Services at the ARC, immediately, if there is any change in
an order or in the condition of the patient. If HLA- matched, leukopheresis or
therapeutics, please call the Hemapheresis Department (see Blood Services
Telephone Directory, Page ii).
(d)
Platelets, Pheresis will be available for shipment at approximately 1200 hours the day
after a blood donor is scheduled and has donated.
(e)
If you have any questions regarding hemapheresis products, do not hesitate to call
Hospital Services or the Hemapheresis Department.
NOTES: For those hospitals with either laboratory or nursing personnel trained in platelet pooling
and/or the so-called syringe technique, a "flush" of the product bag is acceptable. When such
experienced personnel are not available, simply allowing the product bag to drain by gravity is
adequate. One also has the alternative of allowing a little saline to run into the product bag
from a Y-tubing set as a "flush."
As with other transfusions, DO NOT USE glucose (dextrose) solutions, or non-isotonic saline
solutions as a "flush"; use ONLY sterile, normal saline (NS) (also refer to section under
“Blood Products”).
B. HLA-Matched Single Donor Platelets (SDP)
1. INDICATION for use:
For thrombocytopenic patients who have evidence of alloimmunization to platelets and have
become refractory to random donor platelet concentrates and/or non HLA-matched SDP.
2. The following should be considered by the physician attempting to optimize the use of platelet
products:
(a)
Thrombocytopenia
i.
Platelet count less than 5,000-10,000/ml with increased risk for bleeding.
ii. Platelet count more that 20,000/ml and undergoing invasive procedure or actively
bleeding.
(b)
Alloimmunization: prima-facia evidence is established when 24-hour Corrected Count
Increment (CCI) is less than 7,500. Use the following formula to calculate the CCI:
Post transfusion - pre-transfusion platelet count/mL
CCI = __________________________________________ x BSA(m2)
No. of platelets transfused x 10-11
BSA = Body Surface Area
(c)
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HLA typing should be performed early in the patient's hospital course before transfused
cells complicate the patient’s typing. This will also expedite the selection of donors.
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(d)
If no other clinical factors for platelet destruction are present, e.g., DIC, sepsis, fever,
splenomegaly, brisk hemorrhage or drug-induced destruction; then HLA matched
products may be indicated when (a) and (b) are satisfied.
3. If any of the above-mentioned clinical factors in (d) are present, and a 1-hour post transfusion
CCI done subsequent to the next random donor platelet transfusion is less than 10,000, then
HLA-matched platelets are a reasonable and productive means of managing the patient.
NOTE: For patients being maintained on SDP, switching to random platelet concentrates may
sometimes lead to a better patient response. The explanation for this phenomenon is that
by using a pool of donors, there is a better chance that some of the donors’ platelets will
not have antigens to which the patient has developed antibodies. Another tactic that
sometimes is effective is to use only ABO specific platelets.
C.
V.
EXPECTATION OF PRODUCTS
1. Due to our donors’ need for advance notice, and the time required for collection, testing, and
distribution, we strongly recommend all orders to be in the Apheresis Department a minimum of
36 to 48 hours in advance of need.
2. On day one, products are drawn. Testing and labeling will normally be completed by noon on
day two.
3. All HLA-matched products will be irradiated unless we have been requested to do otherwise.
4. Products will be delivered to the hospital as soon as they are processed and transportation is
available.
5. Emergencies will be expedited as quickly as possible.
6. HLA-matched platelets follow the same guidelines as for the other platelet products.
Apheresis Leukocytes (Granulocytes/Platelets)
A.
INDICATIONS
1. Severe, reversible neutropenia <0.5 x 109/L, due to transient marrow suppression.
2. Documented infection, or sepsis, unresponsive to antibiotics.
3. Minimum of 3 granulocyte transfusions will be attempted.
4. Relative contraindication for use of granulocytes is a patient on Amphotericin B.
B.
INFORMATION FOR THE LABORATORY:
1. Pretransfusion testing should be performed using the same procedures used for whole blood, that
is, crossmatching is required. The donor's red blood cells shall be ABO compatible with the
recipient's plasma.
2. Rouleaux formation may be noticed due to the presence of the volume expander hydroxyethyl
starch (HES), used during the collection to enhance yield.
3. The product outdates in 24 hours, and should be administered as soon as possible after collection.
If the product container is entered for any reason, the dating period for the product must be
reduced to 4 hours from the time of entry or the remaining shelf life, whichever is shorter.
4. If temporary storage is required, the product should be maintained at 20-24ºC ("room
temperature") without agitation.
5. Platelet/white cell aggregates are commonly seen in the product. However, white cell aggregates
which form during compatibility testing may imply the presence of white cell antibodies. If so,
monitoring the patient closely for at least the first 15 minutes of the infusion is strongly advised.
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C.
VI.
INFORMATION FOR NURSING:
1. Standard transfusion sets with standard filters are recommended.
2. Do not use microaggregate or microemboli-trapping transfusion filters. Pore size of any filter
used should be 100 microns or larger.
3. The product should never be transfused in less than four (4) hours. If the patient tends to chill,
flush or become congested, the transfusion rate should be further decreased or stopped, but not
removed, until the attending physician has been consulted. Saline may be used to "keep open" IV
access if the transfusion must be interrupted.
4. The most important signs and symptoms to monitor are those relative to pulmonary function:
labored breathing, pulmonary congestion, dyspnea, tachypnea, etc.
5. It will, at times, be necessary to treat the patient with antihistamines or antihistamines plus
meperidine, and allow at least (6) hours for transfusion.
6. It is always prudent to confirm the patient's identity and to have the laboratory re-confirm blood
types of product and patient when an untoward reaction occurs.
7. The most common cause of a "transfusion reaction" with leukocytes is a too rapid infusion rate.
8. Granulocytes are ordered by the attending physician and should be closely coordinated with the
ARC Apheresis Services due to required pre-medication of donor(s) and special processing
during the collection. Collections that have the highest yield will be from donors who have been
pre-medicated with Prednisone 12 hours prior to the apheresis procedure.
9. Since leukapheresis procedures require at least 2-1/2 to 3 hours of donor time, and products
outdate in 24 hours, early morning appointment times are made. If the product is not going to be
needed that day, the ARC Apheresis Services must be notified by the responsible ward personnel
by 0800. The Apheresis Charge Nurse will be responsible to coordinate with the customer the
approximate time product will be delivered.
10. Granulocyte product needs to contain at least 1 x 1010 granulocytes in total. These products may
contain significant quantities of platelets.
CONTACT INFORMATION
Apheresis Services Contact: ............................................................................ Charge Nurse
Phone: ......................................................................................................Local ARC Center
Hours:....................................................................................0800 - 1700, Monday – Friday
After-Hours: ............................... Contact Hospital Services for On-Call response Personnel
VII.
THERAPEUTIC APHERESIS SERVICES (Tulsa & Harlingen only):
Therapeutic apheresis involves the selective removal of specific blood components in the treatment of a
variety of diseases. Consultation by the patient's physician with the Red Cross Medical Director or
designee is recommended before any scheduling occurs. Consultation is also available to determine if
therapeutic apheresis will be beneficial for a specific case.
A. Types of Therapeutic Apheresis Performed:
1. Therapeutic Plasma Exchange via Plasmapheresis: to remove abnormal or excess plasma
constituents such as immune complexes, autoantibodies, mediators of inflammation such as
complement or other disease-causing plasma factors assumed to be present. The plasma removed
is replaced by a specifically determined volume of saline, fresh frozen plasma or serum albumin,
or a combination of these.
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2. Therapeutic leuko/platelet apheresis: to remove excess or abnormal cells/platelets. It can be used
to effectively remove large numbers of leukocytes or platelets to prevent the complications
secondary to extreme leukocytosis or thrombocytosis.
3. Therapeutic plasmapheresis with ProSorba® column: to remove (presumed) autoantibodies from
the circulatory system in some auto immune diseases, such as ITP and rheumatoid arthritis.
Consultation with American Red Cross Medical Director or designee should be sought as her/his
approval is required. In addition, the ProSorba® column must be provided by the hospital.
B.
REQUESTING SERVICE/OBTAINING CONSULTATION FOR THERAPEUTIC APHERESIS:
1. Requests for Therapeutic Apheresis:
(a) To order therapeutic apheresis, call the ARC Apheresis Services, and ask for the
Supervisor, or designee, Monday through Friday, 8:30am - 4:30pm, except for holidays. If
needed, the ARC Medical Director can be consulted.
(b) For after-hours, Monday through Friday, 4:30pm - 8:30am, weekends and holidays, call
Hospital Services who will channel all requests to the Supervisor or designee on call. If
needed, the ARC Medical Director can be consulted.
2. The Red Cross Blood Services reserves the right for final approval of requests based on staff and
equipment availability and rationale for the apheresis procedure.
3. Any procedure of a non-urgent nature will be performed Monday through Friday, except
holidays, 8:30am - 4:30pm by prearrangement.
4. Any procedure of an urgent nature will be provided on an "as soon as possible” basis. Response
time reflects the availability of trained staff, the time needed to mobilize personnel, to
prepare/pack materials and supplies, to transport personnel, supplies, and equipment to the
hospital, etc.
5. The promptness in which an apheresis procedure can be started will be enhanced by having an
adequate venous access established ASAP and all pertinent tests ordered and performed, with
results provided to the ARC.
6. A contract for the provision of therapeutic apheresis services by the ARCBS (See Attachments)
must be signed by the hospital administration before therapeutic procedures can be performed. If
necessary, transfer of the patient should be considered if warranted.
7. All therapeutic procedures will be performed in the hospital in a suitable location as the patient's
condition dictates. This includes procedures done as an out-patient. At this time, no procedures
are performed at the ARC centers or in other non-hospital settings such as a physician’s office.
The contract allows the ARC nurse to perform the therapeutic procedure only. It is the
responsibility of the hospital or out-patient clinical staff to provide all other patient care needs
including medication administration.
8. A physician's written order must be in the patient’s chart and available to the ARC apheresis
nurse(s) when they arrive at the hospital. A "Request for Consultation for Therapeutic Pheresis"
(See Attachments) should be filled out and signed prior to, or at the earliest possible time after
the first procedure has started.
9. Venous access should be adequate so as to establish one free-flowing blood line, preferably using
a 16-gauge needle/catheter. If peripheral venous access is limited, a central line may be used. A
consultation between the ordering physician and the ARC apheresis team or ARC Medical
Director or designee, may be necessary to evaluate what is “adequate venous access.” Examples
of adequate venous access include:
(a) A femoral line with a 14-gauge catheter when a limited number of procedures will be
performed.
(b) A Quinton double-lumen dialysis catheter, or similar, for procedures expected to extend
over a prolonged period. This also is the preferred access for most procedures.
10. Partial fees will be charged if the procedure is canceled after set up or if personnel are already in
attendance on site.
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SPECIAL COLLECTIONS
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AUTOLOGOUS DONATIONS
I.
DEFINITION:
An Autologous Donation is the collection and storage of blood or blood components from a donor/patient
for subsequent re-infusion to him/herself.
Informational material for patients and/or physicians is available upon request from the American Red Cross
Blood Services, to aid in the explanation of the donation process.
NOTE: Autologous blood must not be released for general use—such units are to be used ONLY
by the donor.
II.
GENERAL POLICIES AND PROCEDURE:
A.
Patient/Donor needs to discuss autologous donation with his/her physician several weeks prior to the
scheduled elective operative procedure.
B.
The physician's order for autologous collections must be submitted on a prescription pad or preferably
on the ARC’s “Special Collection Order” (Attachment). If the physician’s order is submitted on a
prescription pad, it must include the following information:
1.
2.
3.
4.
5.
6.
Name of patient—first and last names--phone number, and Social Security Number
Specification of component(s) to collect
Indication of number of unit(s) to collect for each component type desired.
Surgical procedure
Date and place of surgery
Physician’s signature
NOTE: The "Special Collection Order" form must be completed by the time of collection.
C.
Appointments are required.
1.
The Tulsa office of the American Red Cross will contact the patient to schedule his/her
appointment(s). Tulsa phone number are:
Toll free:
1-800-877-1624
Local (Tulsa, OK):
1-918-831-1219
D.
When requested the Donor/Patient will be required to prepay all fees including freezing fee, if
applicable, at the time of donation--Medicaid, Medicare and Workmen's Compensation donor/patients
are exempt. Prepaid status will be displayed on reverse side of autologous tie tag. Waiver of fees
may be considered for persons who have donated as regular allogeneic donors with the ARC; such
situations will be evaluated on a case-by-case basis.
E.
The donation(s) is collected using donor acceptance criteria that are specific for the collection of
autologous units (see below).
F.
At least one donation within a 30-day period must be tested with the standard panel of tests.
However, routinely, each autologous unit is tested.
NOTE:
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Any unit that tests positive for either HIV or HBsAg, or both, requires written acceptance from
both the ordering physician and the Medical Director of the hospital Transfusion Service before
such units can be shipped by the ARC. If either physician does not accept such units, the
ARCBS will not ship units even if the other physician has already given written approval.
Positive results for other tests warrant only written notification of the ordering physician and the
receiving Transfusion Service; approval is not required for the shipment of such units.
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G.
III.
After all requirements have been met, units are labeled and either held until needed or shipped
“immediately.”
REQUIREMENTS AND REGULATIONS
A.
Candidates for autologous donations do not need to meet all the criteria established for allogeneic
blood donors. In general, anyone who is not anemic (hgb/hct >11/33%), and is otherwise healthy and
able to undergo an elective surgical procedure, qualifies for autologous donations.
B.
Individuals who have cardiac and/or respiratory problems have increased potential risk for adverse
effects from donating blood. To minimize occurrence of adverse effects in such persons, completion
of a “Medical Clearance” form may be requested of the patient’s care giver who is taking care of the
particular medical condition(s). This information must be received by the ARCBS before any blood
is collected. A completed form is not a guarantee that autologous donations will be collected—see
Note below. (Our Special Collections Order Form states that Medical Clearance is required for all
patients with cardiac/cardiovascular disease.)
NOTE: The ARC physician makes the final decision regarding acceptability of the patient as an
autologous blood donor; all available information on the patient's medical condition will be
considered in this evaluation on the day of collection. The patient’s physician may be
consulted in this evaluation and will be notified should the donor be deferred and the total
number of units desired not attainable.
C.
When donating blood for oneself, there are no upper age limits. The lower age limit is determined by
the capacity of the child to understand and cooperate. Minors under 17 must have written
parental/guardian consent.
D.
Risks are, in most cases, the same as those for any blood donation. These risks are discussed in a
pamphlet all blood donors are required to read (see Attachments). Obtaining informed consent is
mandatory.
E.
Donating blood for autologous transfusion may be possible during the third trimester of an
uncomplicated pregnancy, with the obstetrician’s approval in the form of a written request from
him/her, subject to approval by the ARC Medical Director/designee.
F.
The frequency of autologous donations is usually one unit per week. The last donation must be no
less than 10 days before the operation. Donating blood more than once prior to surgery may require
iron supplementation, to be prescribed by the ordering physician.
G.
There is no minimum body weight requirement. Those weighing less than 100 pounds will have a
volume withdrawn that is proportionate to their total blood volume.
H.
For certain elective surgeries that may require more than four units of red blood cells, it may be
necessary to make blood donations a few months in advance of surgery. The red cells (and the
plasma if desired) can be frozen and stored until the OR date. The last donation(s) before surgery are
usually not frozen and have the usual storage time as for liquid units.
I.
Other than in situations as described above in section H., the freezing of autologous units requires
an order from the surgeon and is limited to six months storage unless otherwise specified. If not
otherwise specified, at the end of six months, all unused frozen unit(s) will be destroyed. A
specific consent from the patient is required as well as pre-payment of an additional, nonrefundable fee for each unit that is to be frozen.
J.
Frozen units will be thawed and deglycerolized only upon notification by the hospital, and must be
done in advance of the time of need. However, in order to ensure that thawed units will still be
usable (and not expired) when needed, the hospital has to avoid ordering “too early;” keeping in mind
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10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Special Collections
Page 3
that thawed units have a limited shelf life of only 24 hours. This expiration is calculated from the
time that the thawing process starts. The thawing process itself takes a minimum of about 2 hours.
To this, one needs to add the time it takes for delivery so that upon receipt at the hospital, these
thawed units will still have sufficient hours left for their infusion
IV.
PRODUCT CONFIGURATION AND LABELING:
A.
Whole blood collected from the donor/patient can be separated into two products: red blood cells and
plasma; the latter is discarded unless specifically ordered as an autologous unit of Fresh Frozen
Plasma (FFP). The physician should specify if the donation is to be a unit of whole blood (WB) or
packed red blood cells (RBCs). RBC units can be ordered as leukoreduced; otherwise,
leukoreduction is not done.
B.
All units will have an “Autologous Donation” tie tag (see Attachments) attached with the following
information:







Whole Blood Number (WBN) of unit
Patient’s full name, Social Security Number, and date of birth
Date of collection
Date of surgery
Transfusion facility and address tag has City and State only
Physician’s name
Type of component.
On the back of the tie tag is the standard bar-coded ABO/Rh label.
V.
C.
The label on the bag has a “For Autologous Use Only” sticker (see Attachments) with the patient’s
ABO/Rh and expiration date written in.
D.
Any unit with a reactive screening test result will have a “Biohazardous” sticker (see Attachments) on
the bag label.
SHIPMENT AND AVAILABILITY:
A.
The hospital will be notified by fax of the total number of autologous units available for a specific
donor/patient. Units, which have positive test results, may require a verbal or a written note of
acceptance from the medical director of the receiving hospital and/or the ordering physician, prior to
shipment. See NOTE to section II, F, above.
B.
Autologous units are usually sent to the hospital with the regular blood shipment. Special delivery
can be done to meet individual patient’s need.
C.
Should a unit be unavailable due to unforeseen circumstances, the ordering physician will be
notified.
MW: MANUAL: 2292_1
PD: 02/05/16, Administration
Version: 04/01/2000
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Special Collections
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DIRECTED DONATIONS
I.
DEFINITION:
A.
Directed donations are blood donations from persons specifically recruited by a patient or his/her
family for the patient’s exclusive use. Directed donations may also be medically indicated when a
physician has determined that the intended recipient’s needs are best met by a donation from a specific
individual. An example of this is a newborn suffering alloimmune thrombocytopenia for which
platelets from the mother are most suitable.
B.
Informational material on directed donations is available upon request to aid in the explanation of the
donation process.
NOTE: Directed donations may be contraindicated in certain situations especially those with the potential
for leading to “sensitization” of the recipient and potential future adverse clinical conditions such as
hemolytic disease of the newborn or GVHD. A special form of understanding may be required
should a directed donor persist in wanting to donate in such situations.
II.
GENERAL POLICIES AND PROCEDURE:
A.
All requests for collection of directed donations require a written order from the patient's physician.
The physician’s order for directed donations can be submitted on a prescription pad but preferably on
the “Special Collection Order” (see Attachments). If a prescription is used it must contain all the
information required on the Special Collection Order form.
NOTE: A completed “Special Collection Order” form will be required at the time of collection.
B.
The group and type, if known, of recruited donors should be ABO/Rh compatible with the
prospective recipient. However, if Whole Blood is ordered, only blood from donors who are ABO
specific and Rh compatible can be given to the patient.
1)
2)
For those who do not know their ABO/Rh, this testing is offered by the ARC for a nominal
fee. ABO/Rh testing also can be obtained through a local hospital or private doctor’s
office.
However, directed donors do not need to know their ABO/Rh status because the ARC
routinely tests all donations. Therefore, should a unit be collected and then subsequently
determined to be ABO/Rh-incompatible with the intended patient, the unit is released into
the general inventory. Any fees paid are non-refundable.
C.
Appointments are required and are made by calling.
D.
Each unit drawn as a directed donation will have a special, non-refundable handling charge added
for this special service. Full payment is expected at the time of donation.
E.
Directed donations cannot be collected on a stat basis. In order to provide this service adequately
and safely, donors must be drawn a minimum of 10 calendar days before the date needed, Monday
through Friday, during normal hours of operation.
F.
For emergency needs, the ARC Medical Director/physician designee must approve all requests. In all
such cases, ‘emergency release’ will be required for labeling and shipment as test results are not
usually available in time. [Emergency release requires the approval of both the hospital Transfusion
Service MD (or the “requesting physician”) and the ARC Medical Director/physician designee.] A
nonrefundable stat fee must be pre-paid at the time of donation.
MW: MANUAL: 2292_1
PD: 02/05/16, Administration
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American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Special Collections
Page 5
G.
Directed donors must meet all standard criteria applicable to allogeneic donations with the exception
of the “limited exposure directed donation (LEDD)” in which donations can occur more frequently
than otherwise allowed. Such donors require examination by a physician on the day of donation who
verifies that they still can donate safely. The donor must present with written verification from the
physician.
H.
All units drawn as directed donations will be collected in Adsol with a 42-day outdate. Whole Blood
will not be routinely available as a safety measure, to reduce the likelihood of ABO incompatibility
(see section “B” above). Red Blood Cells will be sent to the hospital blood bank when processed.
I.
American Red Cross has mandated that all units from donors who are blood-relatives of the patient
will be irradiated prior to distribution to hospitals. Exceptions to this will be hospitals who request to
perform their own irradiation.
J.
In the event that the intended recipient does not use the directed donation, it may be used for another
patient(s) at that hospital, referred to as “crossing over.” The hospital can choose to crossover such
unused directed units itself, or return the unit(s) to the ARC. Once returned to the ARC, the unit(s) is
no longer available for the designated patient.
NOTE: Units returned to the ARC may receive credit (partial or complete) dependent upon various
factors—please call ARC for specifics.
III. PRODUCT CONFIGURATION AND LABELING:
A.
A “Directed Donation” tie tag (Attachments) will be attached to each directed donated unit and
will contain the following information:









B.
Patient's/Recipient's Name, Date of Birth, and Social Security Number
Hospital
Physician
Date of Surgery, if applicable
Date Drawn
Product ordered
Whole Blood Number (WBN)
LEDD
Indication if donor is a blood relative of the intended recipient
A “Special Handling” tie tag (Attachments) is attached to units from blood relatives for which
irradiation is required as indicated on the “Directed Donation” tie tag.
IV. SHIPMENT AND AVAILABILITY
A.
When the processed unit is released to Hospital Services, it usually is sent with the regular blood
delivery unless otherwise arranged.
B.
Due to multiple factors, the collected directed donor unit(s) may not be available when needed. In
addition, the blood transfusion needs of the recipient may exceed the units collected and available.
The patient and recruited donors should be made aware of these limitations.
MW: MANUAL: 2292_1
PD: 02/05/16, Administration
Version: 04/01/2000
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Special Collections
Page 6
C.
The only information that will be released is the number of units available; all other information is
strictly confidential.
D.
Directed donations are subject to all the requirements for standard, allogeneic blood and may have
to be destroyed as determined after collection. However, depending on circumstances, such nonconforming units may trigger notification of the recipient's physician so that he or she can assess if
the benefits outweigh the risks. As an example, platelets donated by a mother for her newborn
child might be medically acceptable, and even preferred, despite a positive test that otherwise
would mean the destruction of the donation.
E.
If an insufficient number of units is collected, or collected units had to be destroyed, arrangements
for other donors may be made if time allows.
F.
Should a unit be unavailable due to unforeseen circumstances, the ordering physician will be notified.
THERAPEUTIC PHLEBOTOMY SERVICES
I.
II.
PURPOSE:
A.
For certain diseases or medical conditions, the periodic or occasional removal of a ‘unit’ of whole
blood is an effective treatment. Most of the diseases are ones in which iron blood levels and iron
stores are abnormally elevated and can lead to damage of organ systems, such as hemochromatosis.
Therapeutic phlebotomy removes the excess iron, thus preventing the subsequent harm.
B.
An abnormally high hematocrit and its associated adverse effects on adequate perfusion of critical
organs characterize other conditions, such as polycythemia. In these cases, therapeutic phlebotomy
is effective by reducing intravascular red cell mass and thus improving perfusion.
GENERAL POLICIES AND PROCEDURE:
A.
A prescription is required for initiating this clinical treatment. An order received on the
physician’s prescription pad is acceptable to initiate treatment. The ARC will then send a blank
“Therapeutic Phlebotomy Order” form (see Attachments to the physician for completion which
will be required by the time of the second procedure.)
1) All orders are effective for a maximum of one-year unless otherwise specified.
2) The ARC will send, by fax , a blank ARC form to the patient’s physician prior to the
expiration of the order or before the next visit.
3) Telephone requests are acceptable for scheduling purposes only.
B.
The following information is needed:
1)
Patient’s full name
2)
Work/home telephone number(s)
3)
Doctor’s name and address
4)
Doctor’s telephone number and fax number
5)
Patient’s diagnosis including pertinent clinical/laboratory information
6)
Any co-existing conditions that might increase the risk for an adverse reaction due to
phlebotomy
7)
Frequency of procedures
MW: MANUAL: 2292_1
PD: 02/05/16, Administration
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American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Special Collections
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8)
9)
Amount/volume of blood to remove per procedure (500 cc is the standard volume)
Hematocrit level at which phlebotomy is NOT to be done
NOTE: Any changes to the above may be called, faxed or mailed to the ARC.
C.
Appointments are required. Please refer to Attachments for the nearest location and its
telephone/fax numbers.
D.
Phlebotomies are performed using essentially the same procedures and techniques as for
autologous collections. However, some donor findings regarding health history, current state of
health, or vital signs, are not reasons for deferral since the blood collected cannot be used for
transfusion under current regulations. The ARC Medical Director has the ultimate authority to
postpone treatment if he/she determines that phlebotomy would be detrimental to the patient.
E.
The ARC will send a summary report to the patient’s physician on an annual basis or as befits the
frequency and cumulative volume of blood removed.
F.
A fee is assessed for this service and payment is expected at the time of the procedure. As the
ARC does not have the means to manage insurance filing and billing, those with insurance
coverage for this procedure are expected to request reimbursement for payments they have made.
Waiver of fees is considered for “hardship” situations, and evaluated on a case-by-case basis.
MW: MANUAL: 2292_1
PD: 02/05/16, Administration
Version: 04/01/2000
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
EDUCATIONAL SERVICES
MW: MANUAL: 2292_1
PD: 02/05/16, Administration
Version: 04/01/2000
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
EDUCATIONAL SERVICES
Page 1
EDUCATIONAL SERVICES
I.
AABB AND ASCP TELECONFERENCES:
The Southwest Region provides live broadcast of selected American Society for Clinical Pathology’s and
American Association of Blood Banks’ teleconferences (varies by location). For information on upcoming
educational opportunities or for information about past teleconferences, please contact Regional Accounts
Account Manager.
II.
MEDIA:
A list of videotapes that can be checked out is available through the Regional Accounts Manager. Many
of the tapes address issues encountered by all blood banks.
III.
IN-SERVICES:
Various topics are available for presentation on-site at hospitals to Laboratory Staff, Nursing Staff as
well as Medical Staff. Many of these meet the requirements for CME Class 1 credit. Some sample
titles include:
 Updates in Transfusion Medicine (covering the most recent topics of interest)
 Emerging Transfusion-Transmissible Infectious Diseases (including WNV)
 Basics of Transfusion Medicine (good introduction for those less experienced as well as
good “refresher” for the experienced)
In addition, the ARC Medical Director welcomes suggestions for “customized” presentations. To
arrange for a presentation or for more information, please contact the Regional Accounts Manager,
below.
IV.
EDUCATIONAL EVENTS
Throughout the year the region will sponsor events where different speakers present a variety of topics
relating to transfusion medicine and blood banking.
Regional Accounts Manager
Phone: 469-341-1015
MW: MANUAL: 2292_1
PD: 02/05/16, Administration
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American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BILLING
MW: MANUAL: 2292_1
PD: 02/05/16, Administration
Version: 04/01/2000
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BILLING
Page 1
BILLING AND PROCESSING FEE SCHEDULE
I.
II.
BILLING
A.
The ARCBS invoice details the following information for each unit/component:
 product code (number)
 product description/name
 order number
 transaction date
 whole blood (unit) number (WBN)
 ABO/Rh type
 quantity
 dollar amount
B.
The invoice includes all distributions, returns and transfers. Invoices will be received four times
a month via mail or email.
C.
Invoice summaries will be sent out on a monthly basis.
D.
Past due accounts (31 days or later from date of invoice) are subject to late fees. Please refer to
your most recent hospital contract for the specific terms that apply to your account.
E.
For account reconciliation: ARCBS Accounts Receivable Specialist
Phone: 918-831-1130
F.
Remit payments to:
American Red Cross Biomedical Services
P.O. Box 730040
Dallas, TX 75373-0040
PROCESSING FEE SCHEDULE
The fee charged for blood and blood products is a processing fee; the blood itself is a gift made by a
volunteer blood donor. These fees are based on the actual costs that are needed to recruit donors, to
draw the unit of blood, including the cost of materials and supplies and the expertise of trained
personnel, to perform eleven routine laboratory tests, to process and separate the unit into various
components, and to store and distribute the actual products. Other costs incurred by the Blood Center in
its mission of maintaining a safe blood supply, include the salaries for highly trained professionals who
provide support to donors, hospitals, healthcare providers, other ARCBS staff, etc., and the routine
expenses incurred by any business, such as telephone service, utilities, office supplies, and capital
expenditures such as delivery vehicles (and their maintenance), and mobile equipment. Therefore, there
is no charge to a blood recipient for the actual blood or blood component given, donated by a volunteer
donor.
A copy of the current processing fee schedule is available by contacting the Regional Accounts
Manager or ARCBS Administration. A thirty-day notice will precede any change in the processing fee
schedule.
III.
PRODUCT CODES
Attachment XII displays the Product Codes currently used by the ARC as well as the property codes for
services provided, along with the coinciding HCPCS and/or CPT code. Contact the Regional Accounts
Account Manager for more information on billing third party payers for blood, blood product and
related services.
MW: MANUAL: 2292_1
PD: 02/05/16, Administration
Version: 04/01/2000
American Red Cross, Blood Services, Southwest Region
10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100