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Sources Sought The Portland VA Medical Center is issuing this sources sought as a means of conducting market research to identify parties having an interest in and the resources to support a requireme... Sources Sought The Portland VA Medical Center is issuing this sources sought as a means of conducting market research to identify parties having an interest in and the resources to support a requirement for blood and blood products for a base period and 4 option years. The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified sources. This is not a request for quotations. The Department of Veterans Affairs, NCO20 is looking for sources of the following: STATEMENT OF WORK (SOW) Background: This contract is needed so that the Portland VA Healthcare System (VAPORHCS) laboratory transfusion service (Blood Bank) can supply blood and blood products as required throughout the hospital. Scope: Supply blood and blood products to VAPORHCS on a Routine, ASAP and STAT basis. Approximately 2400 unit s leukocytes reduced RBCs 700 units Frozen Plasma, and other blood products. Specific Tasks: Contractor shall provide healthcare resources as stated herein and in accordance with Public Law 104.262 and 38 U.S.C. 8153. Contractor agrees to provide the following blood and blood components in support of the Portland VA Healthcare System in Portland Oregon. 1. Blood shall be typed for ABO and Rh antigens in accordance with methods recommended in the current edition of Standards for Blood Banks and Transfusion Services and Technical Manual of the American Association of Blood Banks. A sample of blood from each donation shall be tested for Syphilis. Whole blood and/or components shall not be used for transfusion unless the test is nonreactive. In addition, only blood testing negative for antibody to human to human immunodeficiency virus (HIV), for hepatitis B surface antigen (HBsAg) and for anti-hepatitis B core antigen (Anti-HBc) shall be used for transfusion. Blood and components shall not be used for transfusion if the results are outside established limits. All blood shall be collected by the closed system under aseptic conditions and shall be processed in appropriate solutions and the container so labeled. The label shall also bear the expiration date of the contents, which shall not exceed 21 days from date of collection of source blood or 35 days from date of collection of source blood, when collected and stored with anti-coagulant citrate phosphate, dextrose adenine solution (CPDA-1). AS-1 Red Cells (Adsol anti-coagulant) has 42 days from date of collection. All blood supplied will be grossly free of hemolysis, excessive chyle and clots. Notwithstanding anything to the contrary, in the event that the Federal Food and Drug Administration (FDA) issues guidance concerning the bacterial contamination of platelets, vendor has the right to modify this policy in order to comply with such guidance. 2. Contractor shall be currently registered and licensed with the Food and Drug Administration (FDA), Department of Health and Human Services pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, as amended, 21 USC Section 260 and certified by the American Association of Blood Banks. 3. Contractor shall submit proof that they hold an unrevoked U.S. License which is issued by the Director, Bureau of Biologics, FDA under section 351 of the Public Health Service Act, as amended, 42 USC Section 262, as a source of supply for whole blood. 4. All products, if interstate shipment of blood or blood component is involved, must submit a statement that such approval has been authorized under section 251 of the Public Health Service Act, as amended, 42 USC Section 262. All products delivered shall be FDA licensed. 5. The contractor certifies that they shall comply with the requirements outlined below with respect to donors, containers, delivery, etc. 6. Contractor shall submit copies of their annual license and certifications each year, or upon request from the government. 7. Contractor shall submit proof of AABB accreditation and CLIA certification upon request of the government. Donor Requirements: Donor selection must be in accordance with criteria established by the FDA and the AABB. The contractor shall maintain blood donor lists including names, previous name, date of birth, addresses and phone numbers. Contractor s donor identification numbers must be unique to the donor unit and must have a FDA approved numbering schematic. The Contractor shall only provide the VA with 100% "volunteer donor" blood in accordance with FDA rules and regulations effective May 15, 1978 or later revision. A volunteer donor is a person who does not receive monetary payment for blood donation. Benefits, such as monetary time off work, membership in blood assurance programs and cancellation on non-repayment fees that are not readily convertible to cash, do not constitute monetary payment. Blood Products: 1. Whole blood, red blood cells and components shall be supplied in standard FDA licensed collection containers or brand name or equal, with appropriate samples for laboratory work. 2. Contractor, prior to delivery, shall complete the following tests: ABO Grouping RHo(D) Testing Serology (S.T.S.) Irregular Red Blood Cell Antibody Detection Hepatitis B Surface Antigen (HBV-sAg) HIV I/II Antibody Screening Hepatitis C Virus (HCV) Antibody, and Antigen. Hepatitis B Core Antibody (HbcAb) Screening HTLV 1/1I Antibody Screening HIV-1 RNA by nucleic acid amplification HCV RNA by nucleic acid amplification HBV DNA by nucleic acid amplification West Nile Virus RNA by nucleic acid amplification HBV DNA by nucleic acid amplification Trypanosoma cruzi antibodies NAT Test for the Zika Virus. New tests may be mandated during the period of performance of this contract by the Office of Biologics, a division of the Food and Drug Administration. The contractor shall perform any new blood testing that is mandated 3. Blood Shall be furnished labeled as ABO Group and Rh type. 4. Other than in the case of an emergency, the above work shall be completed on all blood and its components prior to shipment. In emergent situations, some blood may be sent before testing is complete. In the event of an emergent situation, products may be released with a statement of justifications for request of incompletely tested blood components. 5. Immediately after bleeding, the blood shall be stored refrigerated between 1 and 6 degrees with fluctuation of no more than 2 degrees Celsius within this range. Freezing shall be avoided at all times. If public transportation of the blood is necessary, it shall be transported in clean shipping containers provided with refrigeration sufficient to hold the blood at 1-10 degrees Celsius if it has been precooled. If the blood has not been cooled, the shipping containers shall provide sufficient refrigeration to bring the temperature toward 1-10 degrees Celsius, preferably 1-6 degrees while in transit. 6. All blood and blood components shall be prepared, stored and transported in compliance with the current American Association of Blood Bank standards, and Federal Drug Administration regulations, including appropriate labeling for directed and autologous donations and irradiated products. 7. Routine blood orders shall be delivered as specified within twenty-four (24) hours following request. Requests may be made seven (7) days a week, 365 days a year. As Soon As Possible (ASAP) blood orders shall be delivered within four (4) hours following request. (STAT) and Emergency orders are to be delivered to VAPORHCS within one hour from request and the contractor shall be responsible for the cost of delivery to include use of cabs for delivery. For Emergency orders requiring delivery of incompletely tested blood components, a copy of the "Statement of justification for request of incompletely tested blood components" completed and signed by an authorized physician, shall be returned to the contractor. However, the VA understands that the urgency of the situation and the availability of blood products may preclude this possibility. Contractor needs to be located within the Metropolitan Area of Portland, empty shipping containers, being returned for credit shall be returned at contractor's expense. Contractor shall make delivery services for blood and blood components available to VAPORHCS 24 hours per day, seven days a week, 365 days a year, subject to blood product availability and a lack of force majeure events as set forth in 48CFR52.212-4(f). 8. Both parties agree in the event there is an issue with antibodies and/or compatibility of the blood type requested, or if the product requires washing, volume reduction, additive removal, splitting or other manufacturing processes, the delivery time may be longer than 1 hour. The Contractor shall notify VA immediately in the event the requirement will not be delivered within 1 hour. It is the responsibility of the contractor to arrange for pickup of specimens and delivery of blood products in an emergency. Vendor is responsible for transportation, VA is responsible for transportation costs (see fee schedule). Autologous blood shall be fully tested before being sent out by contractor. Autologous Blood shall be delivered to the hospital blood bank designated by the patient s physician within five (5) working days of collection. All ordering on an as needed basis and be compatibility tested as necessary prior to delivery. Orders may be verbal or written; however, a written record of verbal orders shall be made as soon as practical. Ordering should be based on maintaining inventory targets created and maintained by the VA. Routine orders should be placed using vendor s online ordering system only, prior to the order cut-off time for daily routine delivery. STAT/Emergency needs should be placed in a manner directed by the vendor (phone call or on-line). Two routine deliveries per day is provided at no cost. In most cases, customer inventory targets should ensure they have adequate blood on the shelf with normal usage for a 24 hour period. STAT needs should not be a routine occurrence; however, if it becomes regular, vendor and VA will meet to discuss inventory management and delivery times. Blood shall be furnished for liver transplant surgeries with at least three (3) weeks shelf life remaining before expiration date. This time limit may be slightly adjusted with concurrence of the VAPORHCS to accommodate blood shortages. The supplier must be able to support an order of 20 LRPC, 30 FP, 2 PPH and 2 Cryo on a stat order basis. Able to handle ASAP orders of Antigen negative LRPC totaling 20 units for liver transplants with antibodies. The Contractor shall modify products as requested and as necessary for the protection of the patient, to include, but not limited to leukocyte reduction, washed, and irradiation. The Contactor shall maintain a quantity and/or type specific or type compatible products to include but not limited to the following products in-order to meet the needs of the VA Medical Center: Red Blood Cells all 8 groups Fresh Frozen Plasma (FFP) to include all groups, but not limited to group AB Cryoprecipitate to include all groups, but not limited to group AB Apheresis platelets all 4 ABO groups Credits accrued and used each month will be forwarded on a monthly statement to the POC. If the Contractor is unable to recruit enough donors to meet the community needs and the needs of this Medical Center, it shall be the Contractor's responsibility to import blood products in order to meet the Medical Center's requirements at no additional costs. The VA Medical Center will not be required to provide confidential patient information unrelated to patient care unless it relates to the transfusion. All confidential patient information must be requested through the "Release of Information" office. The VA recognizes there are a limited amount of resources of blood components in the region and will attempt to reduce outdating. The oldest blood components are to be used first when clinically feasible. Units of blood and platelet pheresis products will be received by the VA on a non-consignment basis. However, for inventory control purposes, efforts will be made by the VA to assist the contractor and other facilities in meeting patient transfusion needs. VA will return Red Blood Cells that were crossed matched by vendor as soon as possible after the blood is no longer needed by the intended recipient. When the VA returns units prior to expiration in accordance with the contractors return policy, the contractor shall credit the VA for units which are returned as detailed in the Price Schedule. The estimated quantities are not a guarantee of actual quantities, as the Government does not guarantee any particular volume of traffic described in this contract and in accordance with the terms of this contract, orders for these services will be place with the contractor. VA will, upon request, provide vendor an inventory of blood on hand. The VA understands that no credit will be given for the following, unless transfer or return is preauthorized or requested by vendor. Deglycerolized Red Cells Washed Red Cells Autologous Blood Products Pediatric Units Additive removed Red Cells Leukocytes Fresh Frozen plasma/cryoprecipitate has a shelf life of 1 year and is not returnable due to its tendency to break during transport. VA is responsible for managing frozen product inventory to avoid product outdating. Special processing fees such as for irradiation of blood products. Apheresis Platelets returned with less than 24 hours remaining to outdate. Pathogen Reduced Platelets. Leukoreduced Red Blood Cell units returned with less than 7 days to outdate. Group O red cells regardless of dating. Ability to support/facilitate Plasma Exchanges by vendor if needed Courier System in Place for all blood deliveries. Ability to share inventory for STAT requests with facilities located near us. Continuing Education online program. Frequent meetings with other customers such as a re-occurring committee. Reference Lab with the ability to do complex antibody workups, HLA testing and molecular genotyping. Ability to provide antigen negative units for STAT order (delivered within 1 hour). Physician consults available. Ability to support critical services that require platelet products in a quicker turn-around-time than STAT delivery can provide by committing to have a platelet product on our shelf at all times (24/7) Quality Control: Contractor is required to implement and report on quality control monitors, which will review and monitor the quality and timeliness of the services provided under this contract as agreed upon by both parties. The contractor shall submit a report quarterly to the Contracting Officer s Point of Contact (POC) for review regarding the control monitors. These reports are due: April 1 (for Jan/Feb/Mar), July 1 (Apr/May/Jun), October 1 (Jul/Aug/Sep), and January 1 (Oct/Nov/Dec). The Contractor, throughout the life of this contract, shall meet or exceed the standards of FDA and AABB concerning the recall of blood products and shall participate in look back procedures initiated by the VA Medical Center, so as not to impede the ability of the Medical Center to identify if a patient has contracted a transfusion associated disease as a result of a transfusion. If at any time the contractor fails to maintain FDA licensure and/or AABB or CAP accreditation, the government reserves the right to terminate this contract for cause. The Contractor's records pertaining to potency, safety, compatibility testing and quality of units transfused to VA patient's will be available to the VA Medical Center upon request, with the exception of the identity of the donor. The Contractor shall perform pre-transfusion testing for the VAMC, antibody identification, adverse effects of transfusion investigations, and immunity problem investigations. If the Contractor fails to meet FDA requirements, the Contractor shall continue to supply the VA Medical Center and perform compatibility testing and other testing as stated herein as the agreed upon pricing. No additional charges shall be imposed on the VA if the Contractor must import products. The Government will promptly inspect the blood upon receipt, and report any actual or suspected damage, irregularity, testing or labeling error. The Government shall also promptly report blood lost due to shipping error. The Government will keep complete and accurate records, as required by the law, of patients supplied with blood (product names, lot identifications and quantities), any therapeutic adverse effects and complaints and other blood-related information. Upon discovery, the Government will report possible transfusion-transmitted infections or other serious complications associated with transfusion which may have resulted from blood ( Adverse Event ). The Government will cooperate with the contractor s investigation of any Adverse Event and supply information concerning the recipient of the blood to the Contractor, upon forms provided by the Contractor. VA agrees to conform to FDA and TJC requirements regarding reporting, handling, storage and shipping of blood components. VA is TJC accredited. Contractor shall perform blood storage audits as necessary. VA agrees to appoint a committee, which has the following responsibilities: Review the transfusion of blood, blood components and derivatives in the Medical Center as required by the Joint Commission of Accreditation of Hospitals. Make recommendations to the medical staff concerning the proper usage of blood products. Insure that adequate records of transfusions and transfusion associated reactions are kept. There are risks, side effects and hazards associated with human blood products that cannot be prevented, even through careful blood donor screening and testing. These risks, side effects and hazards are set forth in the circular of information for the use of human blood and blood components as prepared by the American Association of Blood Banks and America's Blood Centers and recognized as acceptable by the US Food and Drug Administration. It therefore follows that the contractor cannot guarantee or warrant the blood in any way. The contractor is not responsible for any loss or damage arising out of the blood unless and to the extent caused by negligence or misconduct or the contractor. This language supersedes and replaces 52.212-4 (o) per the FAR regulation 12.302. GOVERNING LAW: This contract shall be governed, construed and enforced in accordance with Federal Law. MARKETING: Contractor shall not advertise or use any marketing material, logos, trade names, service marks, or other material belonging to the VA without the VA's consent. ORDER OF PRECEDENCE: The terms, conditions, and attachments referenced herein, including any formal written modifications thereto, constitute the complete agreement between the parties and take precedence over any other language, oral or written. ORDER PLACEMENT: Task orders will be issued by the Network Contracting Office 20 to fulfill requirements on an as needed basis. Unit quantities are currently unknown. Each individual task/delivery order will state the unit quantities of supplies and/or services required at time of issuance. Orders will be placed orally, facsimile, or by email. SECURITY REQUIREMENTS: The contractor employees shall not have access to VA sensitive or computer information and will not require routine access to VA Facilities. The contractor employees shall have intermittent access only and will be escorted by VA employees while at VA Facilities. No background investigation is required. FEE SCHEDULE & INVOICING: Task and delivery orders will be issued to order various supplies and services stated in the attached fee schedule. The contractor may give discounts from the stated prices; however, the contractor shall never quote or invoice for more than the stated prices in the given fiscal year. Invoice: The Contractor shall invoice the VA Medical Center Monthly in arrears through the Tungsten Network. Review the information at http://www.tungsten-network.com/us/en/ for invoicing procedures. Vendor bills roughly 4 times per month. Payment: Credits for returned blood may be reflected on the next or current invoice. Depending on when the credit is submitted, it may skip an invoice cycle. However, the invoice cycles are roughly weekly so there isn't much/if any delay. CREDIT FOR RETURNED BLOOD AND COMPONENTS: Credit prices are the same prices as charged in the contract. Full credit shall be given when blood products are sent to the VA with less than 10 days dating and outdate at the VA. Leukoreduced Red Blood Cell units received with less than 10 days (Apheresis platelets with <24 hours) remaining to outdate are eligible for credit if the VA accepts them but is unable to use them. Full credit will be given if all seals on the unit have not been entered and are intact. Full credit will be given if the unit label is clean, unmarred and all labels applied by the VA have been removed. In order to receive full credit, a completed and signed Product Return/Transfer Form must accompany all units returned to Contractor. The VA staff member's signature indicates that the unit(s) was properly stored, not entered, and the unit label is intact. When units for which special testing has been completed are returned for credit, credit will be given for the unit only. Irradiated units required by the VA are not returnable and no credit will be given for the irradiation process. Irradiated units may be eligible for return if requested by vendor. Irradiation will always be credited. ALLOGENEIC RED BLOOD CELLS (All conditions listed must be meet in order to receive credit) Full credit shall be given if returned unit(s) have at least 21+ -days remaining to expiration (outdate). If red cells are delivered to VA with fewer than 10 days shelf life, the VA may return for full credit. Full credit shall be given if the unit has been continuously stored within 1 to 6 degrees Centigrade in a refrigerator that is monitored by an alarm system and recording chart. Contractor may request copies of the temperature records (charts) to document proper temperature storage on units of blood returned to the Center. Full credit shall be given if all seals on the unit have not been entered and are intact. Full credit shall be given if the unit label is clean, unmarred and all labels applied by the VA have been removed. In order to receive full credit, a completed and signed Product Return/Transfer Form must accompany all units returned to Contractor. The VA staff member's signature indicates that the unit(s) was properly stored, not entered, and the unit label is intact. When units for which special testing has been completed are returned for credit, credit will be given for the unit only. Irradiated units required by the VA are not returnable and no credit will be given for the irradiation process. (See above) AUTOLOGOUS AND DIRECTED UNITS Autologous units are not formally returned to the Contractor and no credit will be given. These units should be destroyed by the VA if not used. Directed units can be returned for credit if unit has at least 21+ days remaining to expiration (outdate). The credit shall be for the unit cost, excluding the special handling fees PLATELETS AND PLATELEPHERESIS Vendor will assist to transfer un-needed platelets to another facility as need arises and as possible. Platelets transferred to another facility will receive full credit for the VA. Random donor platelets are not used in the Lewis and Clark Region nor Pacific Northwest. Autologous platelets and autologous platelepheresis are not returnable and no credit will be given. Autologous platelets/plateletpheresis are not manufactured by vendor. Directed platelepheresis is not returnable and no credit will be given. Autologous platelets/plateletpheresis are not manufactured by vendor. Pathogen Reduced plateletpheresis is not returnable and no credit will be given. All allogeneic platelets (random) and apheresis platelets will be given full credit if received on day of outdate (short-dated) if they outdate at the VA. Full credit will be given if the unit has been continuously stored within 20 24 degrees Centigrade on a platelet rotator that is monitored by an alarm system and recording chart. Contractor may request copies of the temperature records (charts) to document proper temperature storage on units of platelets returned to the Center. FRESH FROZEN PLASMA, CRYOPRECIPITATE AND DERIVATIVES These products are not returnable from VA. Cryo and FFP, which have a minimum of 90-days, left until expiration, Contractor will assist with transfer to another Hospital as needed to utilize products. Vendor will not move frozen products after they're received by VA due to the product's tendency to break in transit; however, movement may occur for emergent needs only but this would be rare. Autologous fresh frozen plasma is not returnable and no credit will be issued. Autologous plasma is not collected by vendor. Directed fresh frozen plasma is not returnable and no credit will be issued. Directed plasma is not collected by vendor. All allogeneic FFP, Cryo, and derivatives will not be given full credit, but Contractor will assist with transfer out to another hospital as needed to utilize products. (See prior comments on frozen product movement). Autologous blood products are not returnable. DEFINITIONS ALLOGENEIC: Blood or blood components drawn from a non-related donor for subsequent transfusion to a patient (synonymous with homologous). ANTIBODY WORK-UP: Serological work-up performed on potential transfusion recipients, per patient per episode (set of examples); may be defined as simple or complex. As Soon As Possible (ASAP) Shipments of blood products to fill a request for a waiting outpatient, or a non-life threatening need, or to replenish a depleted inventory of a particular blood product which has been used since the previous routine delivery. ASAP orders must be delivered within 4 hours. AUTOLOGOUS: Blood drawn from a donor-patient for subsequent transfusion; in this case, restricted to pre-deposit units of blood, i.e., not including intra-operative or post-operative blood salvage. BLOOD GROUP: ABO Blood group plus the Rho(D) type of the unit, specifically 0+, 0-, A+, A-, B+, B-, AB+, AB-. CMV NEGATIVE: Unit from a donor who has been screened for antibody to Cytomegalovirus and deemed to be negative. Use of CMV negative blood components are indicated in those patients who are undergoing transplantation or are otherwise severely immunocompromised. COMPONENT (BLOOD COMPONENT): Portion of a unit of whole blood which has been physically separated by some mechanical means, e.g., centrifugation. CRYOPRECIPITATE: Plasma component which has been prepared to contain high concentrations of Factor VIII and fibrinogen. It is stored in the frozen state and thawed immediately prior to transfusion. Product is used for the treatment of specific coagulation factor deficiencies, such as von-Willebrand's Disease, hypofibrinogenemia and uremic thrombocytopenia which have been shown to be irresponsive to DDAVP treatment. DERIVATIVE: Portion of a unit of whole blood or blood component which has been chemically separated by some type of fractionation process. Examples include albumin, plasma protein fraction, intravenous gamma globulin, and various coagulation products. FRESH FROZEN PLASMA (FFP): Plasma component that is stored in the frozen state and is thawed immediately prior to transfusion. Used for the treatment of significant multiple coagulation factor deficiencies or congenital factor deficiencies not treatable by cryoprecipitate These may be associated with massive transfusion, severe liver disease, disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenia purpura, but not as a volume expander. Fresh frozen plasma 24 (FP24) is plasma frozen within 24 hours of collection and contains reduced levels of Factor VII and normal levels of Factor V. FP24 may be used interchangeably with FFP unless used to treat Factor VII deficiency. HOMOLOGOUS: Blood or blood component drawn from a non-related donor for subsequent transfusion to a patient (synonymous with allogeneic). IRRADIATED COMPONENT: Blood component that has been subject to a minimum central dose of 2500 cGy of irradiation. LEUKOCYTE-REDUCED BLOOD COMPONENTS: Cellular products prepared by an approved filtration method. NOTIFICATIONS: Vendor will promptly notify Customer when information indicates that blood may deleteriously affect a transfusion recipient; provided, however, that vendor will not reveal the identity of any blood donor. With respect to vendor-manufactured blood, vendor will provide the following notifications to the Customer: (a) within three calendar days if blood collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection; (b) within forty-five (45) days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by the FDA; and (c) as set forth in 21 C.F.R. 610.48(b)(3). Under no circumstance will vendor ever reveal the identity of the blood donor. Upon discovery, Customer will report possible transfusion-transmitted infections or other serious complications associated with transfusion which may have resulted from blood ("Adverse Event"). Customer will cooperate with vendor s investigation of any Adverse Event and supply information concerning the recipient of the blood to vendor, upon forms provided by vendor. PLATELET ADDITIVE SOLUTION (PAS): A plateletpheresis component suspended in variable amounts of patient plasma and an approved platelet additive solution. PATHOGEN REDUCED (PR): is a post-collection manufacturing process intended to reduce the risk of certain transfusion-transmitted infections. Pathogen reduction technology employs a combination of ultraviolet (UV) irradiation and photosensitizers to damage pathogen nucleic acids, preventing replication and growth. Technology is referred to pathogen reduction, component itself is referred to as pathogen reduced. PLATELETPHERESIS: Platelet component which is drawn from a donor using apheresis equipment, is stored in the liquid state, and is roughly equivalent to six to eight units of random platelets. Used for the treatment of significant thrombocytopenia as indicated for random platelets; however, it offers the advantage of minimizing donor exposures to prevent the patient from becoming refractory and/or contracting a transfusion transmitted disease. PLATELETS (RANDOM): Platelet component that is prepared from a single unit of whole blood and is stored in the liquid state. Used for the treatment of significant thrombocytopenia associated with a variety of other clinical conditions, including active bleeding, massive transfusion, disseminated intravascular coagulation, and scheduled invasive procedures. RECALL: A request from the supplier of blood component to return a specific unit(s) which was inadvertently issued to the VA medical center, regardless of the reason, or was issued to the VA medical center prior to the receipt of information about a donor which would have prevented such release. RED BLOOD CELLS (RBC): Red cell components that remain in the liquid state, i.e., not frozen, regardless of anticoagulant. Used for the treatment of anemia which is not treated pharmacologically either due to etiology or time constraints. REGULATIONS: The parties will comply with applicable laws and industry standards, without limitation, requirements, regulations, standards, recommendations, guidelines and directives of the Food and Drug Administration ("FDA") and AABB; U.S. ...