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Administration - American Red Cross

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									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




MW: MANUAL: 2292_1                                                                                           American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                                                  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




MW: MANUAL: 2292_1                                                                                           American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                                                  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.




MW: MANUAL: 2292_1                                                            American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                   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                                                                                       American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                                              10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
INTRODUCTION
Page v




                                                  DONOR CENTERS

OKLAHOMA


Tulsa
                                                                  Southside Donor Center
             10151 East 11th Street                               7717 South Memorial
             Tulsa, OK 74128                                      Tulsa, OK 74133

             PHONE:           (918) 831-1151                      PHONE:               (918) 250-8818
             FAX:                     (918) 499-3967              FAX:                 (918)                         461-9846



TEXAS

             Bryan/College Station                                Longview

             701 University Drive East, Ste#103                   1604 Highway 31
             College Station, Texas 77840                         Longview, TX 75604

             PHONE:           (979) 268-4755                      PHONE:               (903) 753-2091
             FAX:                     (979) 268-4063              FAX:                 (903) 753-7143


             Dallas                                               Waco

             One Medical Parkway, Suite 215                       4224 Cobbs Drive
             Farmers Branch, TX 75234                             Waco, TX 76710

             PHONE:           (214) 943-2863                      PHONE:               (254) 776-8754
             FAX:                     (214) 943-5638              FAX:                         (254) 776-9089


             Harlingen                                            Wichita Falls

             612 Ed Carey                                         1809 5th Street
             Harlingen, TX 78550                                  Wichita Falls, TX 76301

             PHONE:           (956) 428-4543                      PHONE:               (940) 322-8686
             FAX:                     (956)428-7057               FAX                          (940) 322-1791




MW: MANUAL: 2292_1                                                        American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                               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                                                                      American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                             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                                                      American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                             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
location-specific 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                                                          American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                 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                                             (254) 776-8510
Toll Free : 1-888-252-5663                                 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                                                          American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                 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.
2Requires  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.



MW: MANUAL: 2292_1                                                         American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                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/      Approximate
                 Preservative         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.    Hemolytic transfusion reactions—acute or delayed
2.    Allergic and anaphylactoid/anaphylactic reactions
3.    Febrile nonhemolytic reactions
4.    Alloimmunization
5.    Transfusion-transmissible infectious diseases (e.g., HIV/AIDS, HCV, HBV, WNV)
6.    Transfusion-associated graft-versus-host disease (TA-GVHD)
7.    Bacterial contamination


MW: MANUAL: 2292_1                                                                American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                       10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 4




8.    Transfusion-related acute lung injury (TRALI)
9.    Circulatory overload
10.   Hypothermia (with massive transfusions)
11.   Dilution of coagulation proteins and platelets (with massive transfusions)
12.   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                                                           American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                  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.

                                 Approximate
         Anticoagulant             Volume                    HCT                Shelf-Life & Storage
                                                                                  Stored at 1-6ºC
           CPD                      300ml                  65-75%                           21 Days
         CPDA-1                     300ml                  65-75%                           35 Days
    AS-1/-3, or Optisol®          300-400 ml               50-60%                           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.


Potential Adverse Effects

MW: MANUAL: 2292_1                                                          American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                 10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 6




1.    Hemolytic transfusion reactions
2.    Allergic and anaphylactoid/anaphylactic reactions
3.    Febrile nonhemolytic reactions
4.    Alloimmunization
5.    Transfusion-transmissible diseases (e.g., HIV/AIDS, HCV, HBV, WNV)
6.    Transfusion-associated graft-versus-host disease (TA-GVHD)
7.    Bacterial contamination
8.    Transfusion-related acute lung injury (TRALI)
9.    Circulatory overload
10.   Hypothermia (with massive transfusions)
11.   Dilution of coagulation proteins and platelets (with massive transfusions)
12.   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                                                           American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                  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/             Approximate
    Preservative                Volume        HCT          Leukocyte Count            Shelf-Life & Storage
                                                                                      When stored @ 1-6ºC
       AS-1/-3 or              300-400ml     50-60%             < 5 x 106
       Optisol®                                                                                      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.
Bowden RA, Slichter SJ, Sawyer SM, Weisdorf D., et al: A comparison of filtered leukocyte-reduced and cytomegalovirus


MW: MANUAL: 2292_1                                                              American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                     10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 8



(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                                                                American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                       10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
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                              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                                    Shelf Life
                                                                            10 years stored at -65º C
                       <300 cc                   70-80%
                                                                            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. Patients with rare blood types.
2. Patients with multiple antibodies.
3. Patients with febrile reactions unresponsive to leukoreduced blood.
4. 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.




MW: MANUAL: 2292_1                                                         American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
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NOTE: If irradiation is needed to prevent TA-GVHD, , these products must be irradiated as well since viable
      leukocytes are still present.

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                                                          American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                 10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
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       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            Platelet Count*                 Storage                           Shelf Life
                                                           @ 20-24°C, with             5 days (at midnight of the
              45-60 ml             ≥ 5.5 x   1010          continuous, gentle            stated expiration date)
                                                                agitation                          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


MW: MANUAL: 2292_1                                                           American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                  10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
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   b) Surgical patient with continued or increasing “oozing” during surgical procedure, in immediate post-
       operative period, or if anticipating major surgery
Contraindications

1.      DO NOT use if bleeding is unrelated to decreased platelet numbers or to abnormally functioning
        platelets.
2.      Usually not helpful in prophylactic treatment of ITP, immune-mediated drug purpura and hypersplenic
        conditions.
3.      Specifically contraindicated in thrombotic thrombocytopenic purpura (TTP) and heparin-related
        thrombocytopenia because platelet transfusions can precipitate widespread thrombogenesis.
4.      Relative contraindication in autoimmune thrombocytopenia.
5.      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
    non-leukoreduced.
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.      Depends on clinical situation.
2.      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.
3.      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.      Platelets that are ABO incompatible with the recipient's plasma may be used if not grossly contaminated
        with red blood cells (crossmatching not required).
2.      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.
3.      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.
4.      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
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, 23nd Edition).



MW: MANUAL: 2292_1                                                            American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                   10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
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NOTE: Each bag may be flushed with normal saline to maximize the number of platelets pooled or
      administered.




MW: MANUAL: 2292_1                                              American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                     10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 14




              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.”

   Approximat
       e                      Platelet Count*   Leukocyte Count            Storage                                 Shelf Life
    Volume

                                                   < 5.5 x 105        @ 20-24C, with           5 days (at midnight
    45-60 ml          ≥ 5.5 x          1010                           continuous, gentle          of the last day)
                                          [ 8.3 x 105 (AABB               agitation                    Or,
                                            Standards, 23rd                                    4 hours after pooling
                                                Edition)]                                           (use ASAP)
* 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.


MW: MANUAL: 2292_1                                                            American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                   10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 15




4.      Reduce the risk of CMV-transmission (some controversy still exists as some physicians still accept only
        serologically negative CMV-tested units)
5.      Reduce transfusion-induced immunosuppression, and its consequences, such as post-operative
        infections*
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.
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                                                                American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                       10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
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                            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


MW: MANUAL: 2292_1                                                            American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                   10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 17




        stature (e.g., less than 70 kg 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                Platelet     Leukocyte Count                 Storage                                Shelf Life
     Volume                   Count

                                               < 5.0 x 106            @ 20-24C with                    24 hours or 5 days, as
     200-500 ml               > 3 x 1011                             continuous, gentle                  stated on bag label
                                              (if labeled as
                                           leukocyte-reduced)             agitation


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 HLA-
            specific 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                                                             American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                    10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
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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                                                        American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                               10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 19




            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             Granulocyte Count                 Storage                             Shelf Life
    (Approximate Volume)

   Granulocytes Pheresis*                ≥ 1.0 x 1010           @ 20-24oC with                      24 hours,
       (200-300 ml)              (in at least 75% of units       NO agitation                preferably given ASAP
                                           tested)

             “Buffy Coat”            (no set standards)              as above                             as above
              (50-100 ml)

* 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                                                               American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                      10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 20




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.        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.
2.        Use a blood component/recipient set with a standard in-line blood filter.
3.        DO NOT USE leukocyte reduction filters or microaggregate filters.

Prevention of Adverse Reactions and Events

                Adverse Reactions &
               Events to be Prevented                               Measures to Take
                                                Use slow transfusion rate; pre-medicate with antipyretics.
  Chills and fever (non-hemolytic)            Adding a corticosteroid and/or antihistamine may be helpful.
                                             Premedicate with an antihistamine; adding a corticosteroid may
  Allergic reactions                                                    be helpful.
  TA-GVHD                                             Irradiate (preferably just before transfusion)
                                            Use CMV seronegative, repeat donors for babies whose mothers
  CMV seroconversion/reinfection            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                                                              American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                     10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
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                                            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                  Concentration                   Storage                           Shelf Life
        Volume                     (by definition)
        200-300 ml                  Factor VIII                    ≤ -18°C                                   1 year
                               (and other coagulation
                                      factors):
                                      1 IU/ml
                                                              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.      Provides coagulation factors for treatment of most coagulation factor abnormalities (deficiencies or
        dysfunctions), for which no factor concentrates are available.
2.      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


MW: MANUAL: 2292_1                                                                  American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                         10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
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   bleeding, 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, O
                                        A                             A, AB
                                         B                            B, AB
                                        AB                             AB
                              NOTE: Group AB is the “universal donor” of plasma


MW: MANUAL: 2292_1                                                                American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                       10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
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                             components (e.g., FFP, cryo).
3.        Thaw product between 30-37°C with gentle agitation (approximately 30 minutes). Use overwrap to
          avoid contamination of entry ports if possible.
4.        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                                                             American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                    10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
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                                    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                  Concentration                Storage                             Shelf Life
                                 (by definition)
             500 ml           Factor VIII (and other          ≤ -18°C                                 1 year
                               coagulation factors):
                                     1 IU/ml

                                   Fibrinogen:
                                    1 mg/ml              1-6°C after thawing           *24 hours after thawing

                                 (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                                                             American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                    10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 25



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                                                        American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                               10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
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                              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                          Concentration
           Volume                             (by definition)                                Storage & Shelf Life

           200-300 ml                           Factor VIII:                                      Same as for FFP
                                                < 150 IU/U

                              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
transfusion-transmissible 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                                                                  American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                         10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 27




                              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                         Concentration
           Volume                            (by definition)                        Storage & Shelf Life

           200-300 ml           Labile and stable coagulation factors at                Same as for FFP
                               levels comparable to that in FFP with the
                                  exception of: F VIII, F VIII:vWF,
                                        fibrinogen, and F XIII
                                (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                                                             American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                    10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
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Page 28




                                  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.

                                 Concentration
          Approximate         (by definition and by           Storage                            Shelf Life
            Volume                 QC testing)
                                  Factor VIII:                ≤ -18°C                               1 year
              10-15 ml             80 IU/bag                                           6 hours after thawing
                                                          @ 20-24°C after                        OR
                                                             thawing                      4 hours if pooled
                                  Fibrinogen:
                                                                                           (“open system”)
                                  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.

Contraindications


MW: MANUAL: 2292_1                                                          American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                 10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 29




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.      Does not require ABO compatibility and crossmatching is not required; Rh type can be ignored.
2.      Thaw rapidly at 30-37C (up to 15 minutes).
3.      Store at room temperature until transfused because refrigeration may encourage re-precipitation of the
        concentrated Factor VIII.
4.      Cryoprecipitated AHF must be administered within 6 hours of thawing or 4 hours of pooling (“open
        system”), whichever is shorter.
5.      Do not refreeze after thawing.
6.      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                                                           American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                  10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
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                              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                                                            American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                   10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
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                                  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 T-cells/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.      Bone marrow/stem cell transplantation recipients or candidates for bone marrow/stem cell transplants
2.      Congenital immune deficiency syndromes.
3.      Intrauterine (fetal) transfusion, including newborns who had received intrauterine transfusion
4.      Exchange transfusion of newborns
5.      Patients with acute leukemia of lymphoma (including Hodgkins disease)
6.      Directed donation from person who is a blood relative of the intended recipient (see below).
7.      Platelet apheresis product donated by HLA-histocompatible donor (i.e., an HLA-matched platelet
        pheresis donor).
8.      Crossmatch-compatible platelets

NOTE: Other indications are still controversial with practice varying among physicians (see following
section).




MW: MANUAL: 2292_1                                                           American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                  10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 32




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                                                           American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                  10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
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Page 33




                                       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                                                         American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
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Page 34




                                    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          See manufacture’s package          See Expiration date on product
               insert                             insert

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.      Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should
        not receive RhIG.
2.      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                                                            American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                   10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
BLOOD PRODUCTS
Page 35




Dosage

1.      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.
2.      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.
3.      For all other indications, refer to manufacturer’s package insert.

Administration

Refer to manufacturer’s package insert




MW: MANUAL: 2292_1                                                             American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                    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)                     Storage                                      Shelf Life
        125 units/vial (ml)             Refer to manufacturer’s
        625 units/vial (~ 6.25 ml)                 package insert                  See expiration date on product.


Indications

1.      Provides passive immunization against varicella zoster in the immunosuppressed patient and may
        modify clinical disease in those with significant varicella zoster exposure.
2.      Most effective when given within 96 hours of exposure.
3.      Refer to manufacturer's insert for more current indications.

Contraindications

1.      Should not be administered to individuals having a history of severe reactions following administration
        of immunoglobulin.
2.      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:               DOSE:
               Kilograms      Pounds              Units         Number of Vials
                 0-10           0-22              125           1 - 125 unit vial
                10.1-20      22.1-44              250           2 - 125 unit vial
                20.1-30      44.1-66              375           3 - 125 unit vial
                30.1-40      66.1-88              500           4 - 125 unit vial
                Over 40     Over 88               625           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                                                                 American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                        10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
                              HOSPITAL SERVICES




MW: MANUAL: 2292_1                         American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
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                                 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                                                                 American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                        10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
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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
shelf-life. 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 short-dated 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 products.          [For more information, refer to the AABB’s


MW: MANUAL: 2292_1                                                             American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                    10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
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               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                                                            American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                   10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
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                                 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
   pre-authorized 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:




MW: MANUAL: 2292_1                                                          American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                 10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
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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 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)         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.
      c)         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.
      d)         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.
      e)         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.
      f)         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.
      g)         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.
      h)         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.




MW: MANUAL: 2292_1                                                                 American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                        10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
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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                                                       American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                              10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
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                              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                                                           American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                  10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
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                                       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                                                          American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                 10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
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                                               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                                                            American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                   10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
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                    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-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.
2.    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.
3.    All emergency released products are not returnable for credit.
4.    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.
5.    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

MW: MANUAL: 2292_1                                                            American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                   10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
HOSPITAL SERVICES
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             already been established between the stem cell donor and this patient, the expectation would be that
             this donor’s 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                                                               American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                      10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
         REFERENCE LABORATORY




MW: MANUAL: 2292_1            American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration   10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
REFERENCE LAB
Page 1




                                                       REFERENCE LABORATORY


I.      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.


II.     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:


MW: MANUAL: 2292_1                                                                     American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                            10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
REFERENCE LAB
Page 2




                               What is the patient’s ABO group and Rh type?          How strong were the reactions?
                               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.         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.




MW: MANUAL: 2292_1                                                                        American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                               10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
REFERENCE LAB
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             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.

          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.


II.       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                                                                       American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                              10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
REFERENCE LAB
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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.        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.


VI.       Rare Donor Blood

          A.       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.

          B.       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.         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.
                   2.         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.
                   3.         Consultation with the ARC Medical Director may be needed before units are thawed.

          C.       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                                                                        American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                               10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
REFERENCE LAB
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                   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.




                                                  TESTING
                                   LABORATORIES
MW: MANUAL: 2292_1                                                                       American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                              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 high-quality 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.



MW: MANUAL: 2292_1                                                          American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                                 10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
TESTING LABORATORIES
Page 2




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-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.




MW: MANUAL: 2292_1                                                    American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration                                           10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
                              QUALITY CONTROL




MW: MANUAL: 2292_1                       American Red Cross, Blood Services, Southwest Region
PD:10/20/13, Administration              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:

                                                 Minimum
                                                                                                                  Acceptable
                  Component/Type              Sample Size per            Requirement
                                                                                                                  Pass Rate
                                                   Month
                                                 4 units per
                               Non-additive     anticoagulant             HCT < 80%                                    100%
                                                     type
                               Leukoreduced      1% of total        Residual WBC < 5 x 106                             100%
                                   (LR)          production        Red Cell Recovery > 85 %                            100%
                Red                            50 components
                                Apheresis,
               Blood                            per collection        > 50 g Hemoglobin                                 95%
                                   LR
               Cells                               facility
                                                                     RBC recovery > 80 %                               100%
                                                                   Initial Wash < 1000 mg %
                               Deglyceroliz                                                                            100%
                                               4 components                Hemoglobin
                                   ed
                                                                    Final Wash < 160 mg %
                                                                                                                       100%
                                                                           Hemoglobin

            Granulocytes (by
                                              All components        > 1.0 x 1010 granulocytes                           75%
            apheresis)

                                                                      > 5.5 x 1010 platelets                            90%
                                                75% of total      pH > 6.2 (at end of storage)                         100%
                                 Random        production, or,        Volume: 40-70 mL                                 100%
                                               40 components     Color: light straw to light pink                      100%
                                                                   Residual WBC < 5 x 105                              100%
                                              4 units
                                              (minimum) per           > 3.0 x 1011 platelets                            90%
             Platelets
                                              each variable:
               LR                                                                                                      100%
                                               collection                  pH > 6.2
                                                  facility
                                Apheresis                                                                              100%
                                               component        Color: light straw to light pink
                                                  type
                                               machine type
                                               collection          Residual WBC < 5 x 106                             100%
                                                  chamber
                                                                  Factor VIII averages > 80 IU                           n/a
            Cryoprecipitate                    4 components
                                                                 Fibrinogen averages > 150 mg                            n/a




MW: MANUAL: 2292_1                                                                American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                      10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
QUALITY CONTROL
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II.       Quality Control of Shipping Containers

          A.          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.
          B.          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.


III.      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.       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.
                      2.       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).
                      3.       Red Cross staff will coordinate transportation arrangements for the return of blood and
                               blood components.
                      4.       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.

          B.          Follow-up Requirements

                      1.       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.
                      2.       Return the completed form to the American Red Cross by facsimile or in the enclosed
                               self-addressed, 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.
                      3.       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.




MW: MANUAL: 2292_1                                                                      American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                            10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
QUALITY CONTROL
Page 3




MW: MANUAL: 2292_1             American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration   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 918-831-1101 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



MW: MANUAL: 2292_1                                                                  American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                        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.        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.

IV.       Case Investigation Summary

          A.        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.
          B.        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:
                          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
II.       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.



MW: MANUAL: 2292_1                                                                  American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                        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, Swan-Ganz 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 follow-up notification will be sent.




MW: MANUAL: 2292_1                                                                       American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                             10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Post-Transfusion Recipient Management
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   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                                                               American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                     10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
                        QUALITY ASSURANCE




MW: MANUAL: 2292_1                  American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration        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.       Regional Quality Director (RQD) reports to Division QA Director
                               [parallels Regional CEO reports to Division Vice President (VP)]
                      2.       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).

          C.          Current staff in the Southwest Region

                      1.       Regional Quality Director
                      2.       Two Quality Managers
                      3.       One Quality Senior Associate
                      4.       Two Quality Associates
                      5.       Two Quality Specialists


II.          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.       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
                      2.       Review and approve the results of equipment and computer system validations prior to
                               the equipment or software being released for use.
                      3.       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
                               e.     Donor information records

MW: MANUAL: 2292_1                                                                American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                      10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
                                f.   Training records
                                g.   Customer complaint records
                      4.        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.

          B.          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.


III.      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.       Schedules and dates of completion are available to external inspectors/auditors on
                               request.
                      2.       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.


IV.       REGULATORY COMPLIANCE AND QUALITY AUDITS (RCQA)

          A.          Performed by American Red Cross Biomedical Services staff of the National Regulatory
                      Compliance and Quality Audits department.
          B.          Audits occur annually and are system-based.


MW: MANUAL: 2292_1                                                                      American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                            10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
          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.


V.        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.


VI.       PROFICIENCY TESTING PROGRAMS

          A.          College of American Pathologists’ (CAP) Proficiency Testing Programs involve Quality
                      Control and Reference Lab staff of the Southwest Region.

                      1.       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)

          B.          American Red Cross/American Association of Blood Banks Proficiency Testing Program
                      involves the Reference Laboratory staff; samples are received three times/year.


          C.          All results for these proficiency testing programs are monitored by regional senior management
                      staff, including the Medical Director and Quality Assurance staff.


MW: MANUAL: 2292_1                                                                  American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                        10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
          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.




MW: MANUAL: 2292_1                                                                  American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                        10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
                         APHERESIS SERVICES




MW: MANUAL: 2292_1                    American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration          10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
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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


MW: MANUAL: 2292_1                                                                  American Red Cross, Blood Services, Southwest Region
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                               an appointment will be made as warranted.
                    6.         Any requests which do not fall within guidelines for transfusion must be approved by the
                               American Red Cross Medical Director or designee.
                    7.         Please call Hospital Services immediately if there is any change in an order or in the
                               condition of the patient.
                    8.         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).


III.        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.


IV.         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



MW: MANUAL: 2292_1                                                                     American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                           10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
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                                 hospital transfusion 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




MW: MANUAL: 2292_1                                                                    American Red Cross, Blood Services, Southwest Region
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                           (c)   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.       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.


V.          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.

MW: MANUAL: 2292_1                                                                          American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                                 10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
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            C.       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.


VI.          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.

MW: MANUAL: 2292_1                                                                                              American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                                                     10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
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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.


MW: MANUAL: 2292_1                                                                   American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                          10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Version: 04/01/2000
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                   10. Partial fees will be charged if the procedure is canceled after set up or if personnel are
                       already in attendance on site.




MW: MANUAL: 2292_1                                                              American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                     10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Version: 04/01/2000
                   SPECIAL COLLECTIONS




MW: MANUAL: 2292_1               American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration      10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Version: 04/01/2000
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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.         Name of patient—first and last names--phone number, and Social Security Number
                     2.         Specification of component(s) to collect
                     3.         Indication of number of unit(s) to collect for each component type desired.
                     4.         Surgical procedure
                     5.         Date and place of surgery
                     6.         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:                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.




MW: MANUAL: 2292_1                                                                      American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                             10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
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          G.         After all requirements have been met, units are labeled and either held until needed or shipped
                     “immediately.”

III.      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, non-refundable 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

MW: MANUAL: 2292_1                                                                   American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                          10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Version: 04/01/2000
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                     in mind 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.

          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.


V.        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                                                                        American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                               10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Version: 04/01/2000
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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)          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.
                   2)          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                                                                     American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                            10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Version: 04/01/2000
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        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:

                         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

        B.         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                                                                  American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                         10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
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        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 non-
                   conforming 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.        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.

II.       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

MW: MANUAL: 2292_1                                                                  American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                         10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
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                   7)          Frequency of procedures
                   8)          Amount/volume of blood to remove per procedure (500 cc is the standard volume)
                   9)          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                                                                   American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                          10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Version: 04/01/2000
              EDUCATIONAL SERVICES




MW: MANUAL: 2292_1             American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration    10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Version: 04/01/2000
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                                           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                                                               American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                      10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Version: 04/01/2000
                               BILLING




MW: MANUAL: 2292_1                       American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration              10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Version: 04/01/2000
BILLING
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                                          BILLING AND PROCESSING FEE SCHEDULE


I.        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


II.       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                                                                    American Red Cross, Blood Services, Southwest Region
PD: 10/20/13, Administration                                                           10151 E. 11th Street, Tulsa, OK 74128, (918) 831-1100
Version: 04/01/2000

								
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