Q-- Blood and Blood Components for the Atlanta VAMC.

Page 17 of 17 The Department of Veterans Affairs, NCO 7, intends to award a sole source contract to Life South, 9851 Commerce Way Douglasville, GA 30135. Requirement is to provide an alternative source for procurement of blood and blood components by Blood Bank, Pathology & Laboratory Medicine Service, Atlanta VA Medical Center, Decatur GA. This is a Firm-Fixed Pricing. Contract will include a base period and four (4) option years, for a total of five (5) years. Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals or a solicitation for offers. However, parties interested in responding to this notice shall submit technical data, including cost, sufficient to determine capability in providing the same product to Gail Bargaineer, Contracting Officer at [email protected]. by 1400 EST October 21, 2019. All capability statements received by the closing date of this notification of this synopsis will be considered by the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This acquisition is being conducted under FAR Part 12 commercial procedures. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) 621991- Blood and Organ Banks. This is for informational purposes only and not to be considered as a commitment by the Government. Any information submitted to this notice of intent is voluntary. Requirement: Requirement is to provide an alternative source for procurement of blood and blood components by Blood Bank, Pathology & Laboratory Medicine Service, Atlanta VA Medical Center, Decatur, GA. This is a Firm-Fixed Pricing. Background The Blood Center will serve as a secondary source of blood and blood components for VAMC Atlanta and must be located within a 40-mile radius. The blood center s proximity to our facility will be ideal during urgent situations if components are in short supply in the Transfusion Medicine department but needed immediately. The need for a transfusion can be a life and death circumstance on the wards, in the Operating Room, and in the Emergency Department. Executing a secondary contract with a blood supplier located within the 40-mile radius will significantly improve turnaround times for products during these life and death incidents - typically within 60 to 90 minutes. Inventory levels are checked daily and our product needs are based on the number of patients transfused each day. In the past, component prices have been based on negotiations between VISN 7 and the incumbent contractor. The Contractor shall deliver the following items, in suitable containers, to Department of Veterans Affairs (VA) Medical Center, Blood Bank, located in room 2B-168, 1670 Clairmont Road Decatur, GA 30033. Period of Performance: This is a short-term contract for blood and blood services, the contract includes base year and four (4) option year for a total of five years. Base year: October 01, 2019 to September 30, 2020 Option year 1: October 01, 2020 to September 30, 2021 Option Year 2: October 01, 2021 to September 30, 2022 Option Year 3: October 01, 2022 to September 30, 2023 Option Year 4: October 01, 2023 to September 30, 2024 II. The contractor shall provide the following items in such quantities and at such times as may be required to support the Atlanta Veterans Administration Medical Center (VAMC) transfusion needs. Quantities will vary based on the number of highrisk bleeding episodes in surgery, the number of GI bleeds treated at the hospital, and the number of units transfused in Oncology: i. Leukocyte Reduced Red Blood Cells approximately 30 units ii. Fresh Frozen Plasma approximately 100 units iii. Platelets Apheresis approximately 80 units iv. Pre-pooled Cryoprecipitate approximately 20 units v. Irradiated Components approximately 20 units III. VAMC Atlanta Blood Bank Department must adhere to all the blood supplier s return and transfer policies when returning blood and blood components to the vendor or transferring products to other area hospitals. IV. It is the responsibility of the contractor s personnel to park in the appropriate designated parking areas. Parking information and building entry shall be coordinated with each facility COR. V. The Atlanta VAMC does not validate parking nor is the facility responsible for parking violations. PRODUCT FEATURES: I. The vendor shall deliver the required components in FDA (Food and Drug Administration) and AABB (American Association of Blood Banks) approved shipping containers to the Atlanta VAMC Blood Bank Department located in Room 2B-168 at 1670 Clairmont Road, Decatur, GA 30033. These containers shall be validated and packed to ensure proper temperature and the integrity of the components are maintained per Food and Drug Administration (FDA) and American Association of Blood Banks (AABB) requirements. TECHNICAL REQUIREMENTS: I. The vendor must test all blood components as required by the Food and Drug Administration (FDA) and the American Association of Blood Banks (AABB) and ensure that they meet the appropriate quality assurance standards for patient transfusions. The vendor is responsible for notifying VAMC Atlanta Blood Bank Department as soon as possible of all Market Withdrawals or Look-Backs related to units shipped to the consumer. II. The vendor must cooperate with VAMC Atlanta in investigations of possible transfusion transmitted diseases or adverse reactions that may be related to the donor of blood components provided by the blood center. SECURITY: The C&A requirements do not apply, and a Security Accreditation Package is not required. TRAINING: Training is not required. DESCRIPTION AND ESTIMATED COST: List of blood items required: ITEM UNIT OF ISSUE ESTIMATED COST Leukocyte Reduced Red Blood Cells Each Fresh Frozen Plasma Each Platelets Apheresis Each Pre-Pooled Cryoprecipitate Each Irradiated Components Each Renita Scott, MT (ASCP) Phone: 404-321-6111 ext. 202013 Blood Bank Supervisor, Pathology and Laboratory Medicine Service Place of Performance: Authorized personnel in the Blood Bank, Pathology & Laboratory Medicine Service, Atlanta VA Medical Center, Decatur GA will order supplies furnished under this contract. The Contractor shall provide blood/blood components as available when ordered, and Atlanta VA Medical Center shall purchase blood/blood components according to the appropriate fee schedule. The Contractor shall provide the applicable fee schedule with their proposal. Offers shall be considered only from offerors whose blood bank is currently registered and/or licensed with the 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.Prior to award the offeror must submit proof that he holds an unrevoked US 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. Contractor shall maintain licensure and accreditation throughout contract period. If interstate shipment of blood or blood component is involved, the offeror must submit with the offer a statement that such approval has been authorized under Section 251 of the Public Health Service Act, as amended, 42 USC Section 262.The offeror shall certify that he will comply with the requirements outlined below with respect to donors, containers, delivery, etc. Offers will be considered only from blood banks that are able to provide the VA with 100% volunteer donors blood in accordance with the latest FDA rules and regulations. Definition of a volunteer donor: A volunteer donor is a person who does not receive monetary payment for blood donation. Benefits, such as monetary time off from work, membership in blood assurance programs and cancellations on non-replacement fees that are not readily convertible to cash, do not constitute monetary payment. For non-local delivery, unless directed otherwise by Atlanta VA Medical Center, the Contractor shall ship products to Atlanta VA Medical Center by overnight courier. Products ordered by 2:00 p.m., Monday through Friday shall be shipped by air for delivery by the following day. On weekends, the products shall be shipped on Monday for delivery on Tuesday. Packing will ensure the products arrive within the correct temperature range and condition required by FDA/AABB. For local delivery, as applicable, products shall be delivered to the Atlanta VA Medical Center Blood Bank within 1 hour for STAT orders and 4 hours for ROUTINE orders from the time the order is placed with the contractor. Any platelet products received that have a shelf life of less than three (3) days shall be credited if not used before expiration. All Fresh Frozen Plasma shall have expiration dates at least nine (9) months in advance when shipped. The Atlanta VA Medical Center has in place the suitable temperature-monitored freezer and refrigerator for appropriate storage of the products. CRITERIA FOR DONOR SELECTION: The offeror shall maintain a blood donor list including names, addresses and social security numbers. Such list shall indicate the date the blood of a donor was furnished to the Veteran s Affairs Medical Center. Donor selection shall be in accordance with criteria established by the FDA and or American Association of Blood Banks. Blood samples testing positive during unit screening shall not be used for transfusion if the results are outside the established limits by FDA and or American Association for Blood Banks. When FDA or American Association of Blood Banks requires a new test, it shall be performed. COLLECTION, PROCESSING AND TYPING OF BLOOD Blood shall be typed for ABO & Rh antigens and labeled in accordance with the methods recommended in the current editions of Standard for Blood Banks and Transfusion Services and Technical methods and Procedures, published by the AABB. All blood shall be collected by closed system under aseptic conditions and shall be processed in appropriate solutions and the container be labeled. The label shall bear the expiration date of the contents which shall not exceed: 21 days from the date of collection of source blood; or: 35 days from the date of collection of source blood if when collected, is stored with anti-coagulant citrate phosphate, dextrose adenine solution (CPDA1). 42 days from date of collection for blood collected in Adsol. All blood supplied shall be grossly free of hemolysis, excessive chyle and clots. QUALIFICATIONS: All blood and blood components shall be collected, processed, labeled, tested, packaged and shipped in accordance with all regulations of the Food and Drug Administration (FDA), Center for Biological Evaluation and review (CBER), as described in Code of Federal Regulations (CFR) Title 21, Parts 600, 601, 606, 607, 610, 640, and 660, and the State of Georgia Department of Public Health. Also, the contractor shall maintain a current license with the Food and Drug Administration and the State of Georgia Department of Public Health, and maintain accreditation with the American Association of Blood Banks (AABB). The contractor shall be accredited by The Joint Commission (TJC) or meet JC standards and maintain the accreditation or standards. The contractor shall provide current documentation of above licenses and accreditation to the Contracting Officer (CO) with the proposal, and annually or upon organizational change. The Contractor shall immediately inform the Contracting Officer concerning any threatened or actual revocation, suspension, or termination or material modification of a certification or licensure. SPECIFICATIONS: a. Volunteer donors shall make all donations. The contractor shall use reasonable efforts to supply the Atlanta VA Medical Center (VAMC) with related service needs. In the event modification of testing of blood for safe usage, as mandated by FDA, Contractor shall provide the Contracting Officer (CO) with 30 days written notices, and the Contracting Officer (CO) shall issue a modification. b. Should the contractor be unable to provide blood components from its inventory to fill an order, the contractor shall seek other approved sources to obtain such blood components to complete the order. In the event the contractor fails to fill an order within the estimated timeframe given at the time the order is placed, contractor shall notify Atlanta VA Medical Center without delay within reasonable time, of not being able to fill order, and the Government may obtain the item/s elsewhere. c. Contractor shall provide the most current version of the Circular of Information for the use of Human blood and blood components to the participating Atlanta VA Medical Center at no additional charge to the Government. d. Autologous donors that have units drawn at the contractor s collection sites shall not be required to pay any charges. Contractor shall bill Atlanta VA Medical Center for the unit of blood and apply a handling fee for an overall charge. Handling fee is same as e below. All charges are billed to Atlanta VA Medical Center and not the donor. For autologous donors that have units collected at other than the contractor s site may have their blood delivered to the contractor for shipment to Atlanta VA Medical Center. The contractor may charge a processing and handling fee in accordance. Reference laboratory reports shall be provided to Atlanta VA Medical Center, as soon as testing is completed, by telephone, as this shall provide transfusion records to the patients. A written report shall be issued within seven (7) business days following telephone report. Both the telephone and written reports shall be submitted to Atlanta VA Medical Center Blood Bank Supervisor, or his / her designee. Complex cases may take longer to report, and shall be handled on a case by case basis. Mutually agreeable reporting date shall be determined between the Atlanta VA Medical Center Blood Bank Supervisor and the Contractor. ORDERING: Orders shall be placed by telephone, electronic or fax on an as needed basis by an authorized representative of the Atlanta VA Medical Center Blood Bank. The Atlanta VA Medical Center Blood Bank shall assist Contractor in establishing a blood inventory system to insure optimal utilization of blood components. PACKAGING AND MARKING: Blood components shall be labeled in accordance with all FDA requirements, including kind of component, blood group and type (ABO/Rh), expiration date, unique donor unit identification, and storage and handling. Blood components shall be packaged for shipping and transport to ensure the FDA required temperature ranges are maintained: red cell components (1-10 degrees Celsius), frozen plasma components (below minus 20 degrees Celsius), and platelet components (20-24 degrees Celsius). DELIVERIES: There shall be no delivery charges for routine and urgent deliveries. Contractor shall make every effort to make routine deliveries during the time of day suitable to, and as requested by, the Atlanta VA Medical Center. The Contractor shall have sole responsibility of the proper care and handling of all blood and blood components, until delivered to the Atlanta VA Medical Center Blood Bank in accordance with FAR Clause 52.247-35, F.O.B. destination, within consignee s premises. All deliveries shall be delivered to the Atlanta VA Medical Center s Blood Bank. Delivery requirements are seven (7) days per week, twenty-four (24) hours per day. Stock: Planned routine restocking deliveries shall be made on a daily basis as determined jointly by Atlanta VAMC and the Contractor, seven (7) days per week. Routine: Products shall arrive as soon as possible depending upon the quantity of the order, types of products ordered and traffic patterns. An estimated time of arrival shall be given by the Contractor to Atlanta VAMC. Deliveries shall be seven (7) days per week. Deliveries of ordered product shall not take more than eight (8) hours, unless specified otherwise by Atlanta VAMC blood bank. STAT: STAT ordering shall be utilized when restocking, and inventory replacement is needed immediately. Contractor shall notify Atlanta VAMC of the duration of delivery time. VAMCs shall order STAT and expect delivery at a reasonable time. Deliveries shall be seven (7) days per week, twenty-four (24) hours per day. (a1) Atlanta VAMC shall make reasonable efforts to minimize the frequency of STAT deliveries. No additional charge shall be incurred by the Government due to failure of Contractor to deliver on time for routine or STAT orders. Contractor shall make every effort to ensure delivery of autologous blood components are made prior to the scheduled surgery. Deglycerolized cells shall be delivered to the hospitals within 4 hours of preparation to assure adequate dating. Each shipment shall be properly packaged and be accompanied by an itemized shipping list. If Contractor does not have Fresh Frozen Plasma (FFP) at the time order is placed, the Contractor shall notify the VAMC and obtain approval, prior to shipping a substitute product. INSPECTION AND ACCEPTANCE: Inspection of Offeror s Facilities: The right is reserved to thoroughly inspect and investigate the establishment and facilities and other qualifications of any offeror, and to reject any offer regardless of price, if it should be administratively determined as lacking in any of the essentials necessary to assure acceptable standards of performance. Reference Lab Services: Reference lab services for red call antibody identification must be available 24 hours per day and seven (7) days per week and must provide results within four (4) hours for urgent clinical situations, and within 24 hours in non-urgent situations. Plasmapheresis/cytopheresis services must be available 24 hours per day and seven (7) days per week and must be available within four (4) hours of sample receipt for urgent clinical situations. Plasmapheresis and cytopheresis are therapeutic procedures performed on patients that have appropriate clinical indications. Automated equipment is used to perform these procedures. All pheresis equipment, personnel that operate the equipment andsupervisory physicians must satisfy the appropriate regulatory agency guidelines (FDA, AABB, etc.). All pheresis procedures must be under the supervision of a qualified physician. REPORTING AND DOCUMENTATION OF TRANSFERS: Transfer of blood components will be in accordance with the contractor s transfer policy. ADVERSE EVENT REPORTING: VA will notify the Contractor of any possible infectious disease or other serious complication associated with transfusion that may have resulted from any of the blood, including suspected post-transfusion hepatitis, transfusion-associated HIV or HTLV infection, and any other transfusion-associated infections (malaria, babesiosis, bacterial contamination or infection) and death. VA will make available to the Contractor information concerning transfusions to include product names, lot identifications and quantities, any therapeutic adverse effects, complaints or other pertinent information relating to the blood. REJECTED GOODS: The contractor shall remove rejected supplies within 48 hours after notice of rejection. Supplies determined to be unfit for human consumption will not be removed without permission of the local health authorities. Supplies not removed within the allowed time may be destroyed. Atlanta VA Medical Center will not be responsible for nor pay for products rejected. The contractor will be liable for costs incident to examination of rejected products. RETURNS: Credit for returned, unacceptable, transferred, recalled, withdrawn, or rotated blood components shall be included on the billing statement with 30 days of the return. Full credit shall be given by the contractor if for a technical reason the blood component cannot be used, regardless of expiration, provided the Government notifies the Contractor within twenty-four (24) hours of discovery and the Atlanta VA Medical Center Blood Bank completes appropriate documentation. Contractor shall assist with and facilitate the transfer of all blood components to ensure their use. This includes irradiated and other returnable blood components Red Cells. Contractor shall notify Atlanta VA Medical Center, and Atlanta VA Medical Center shall approve Red Cells unit with 7 days or less shelf life remaining prior to delivery. COST: Cost for blood / blood components shall be for ordered product shipped. The contractor shall notify Atlanta VAMC if product to be shipped has been modified. Modified product shall be approved by ordering VAMC either verbally or by facsimile document, prior to contractor shipment of product. Atlanta VAMC reserves the right to refuse modified product offered by the contractor. COVERAGE: Twenty-four (24) hour coverage shall be provided by the Contractor to fill emergency needs when these needs are ordered by Atlanta VA Medical Center. Coverage includes filling blood and blood component orders as requested and in accordance with Work Statement Item 4, Deliveries. Atlanta VA Medical Center Blood Bank shall maintain properly monitored temperature refrigeration storage of blood components, and shall abide by directives dictating handling, storage and shipping of blood components and related documentation. Atlanta VA Medical Center Blood Bank shall make available, on an as needed basis, its inventory of blood components. Any excess of Atlanta VA Medical Center s blood bank immediate patient requirements may be made available for distribution to other hospitals, with approval from the VA Blood Bank. Contractor shall work with the Atlanta VA Medical Center to provide blood component to replenish blood inventory. The Contractor shall own, control and solely be responsible for any loss, destruction or damage to the blood until delivered or received and accepted. After such delivery or receipt and acceptance, the Atlanta VA Medical Center shall own the blood. The Atlanta VA Medical Center also agree and acknowledge that no blood components supplied by the contractor, including part and or derivatives thereof, shall be sold, bartered, traded or exchanged by the Atlanta VA Medical Center without prior authorization from the contractor. Atlanta VA Medical Center Blood Banks shall assist contractor in the maintenance of its blood inventory system. The Atlanta VA Medical Center Blood Bank shall prioritize the use of appropriate blood components with the shortest dating period to ensure optimal utilization of blood components and thereby avoid loss by outdating. TRANSFUSION REACTION: a. Atlanta VA Medical Center Blood Bank shall report to the contractor within twenty-four (24) hours by telephone any life-threatening adverse reactions and if appropriate, make arrangements to have specimen of patient s blood and the remaining portion of blood component in question sent to Contractor for testing at no additional charge to the Government. Atlanta VA Medical Center Blood Bank shall report to Contractor and assist in investigation of cases of suspected adverse transfusion reactions, including post transfusion hepatitis, post transfusion HTVL-1, and transfusion associated HIV infection within a reasonable period not exceeding seven (7) days after learning of the adverse reaction. Atlanta VA Medical Center Blood Bank shall maintain thorough and complete records of the recipients of all contractor products to facilitate investigation of transfusion reaction or product recalls. INVOICE AND PAYMENT: INVOICES - Payment: Payment will be monthly in arrears, upon receipt a of properly prepared invoice. The contractor shall submit all invoices via electronic invoice submission to the VA Financial Services Center through OB10 Electronic Invoicing Services, or alternate service as declared by VA. Contractor shall provide for Atlanta VA Medical Center Decatur, Georgia quick pay discount at 1.5% if payment made within 10 days of received invoice. Contractor shall provide invoices for Atlanta VA Medical Center Decatur, Georgia every 15 days in arrears showing all services provided and components shipped, returned, or transferred. Atlanta VA Medical Center reserves the right to request hard copy of invoices. Invoices shall be sent to the address specified in paragraph c below. c. Properly completed invoices shall be submitted for certification to: ATT: Accounts payable Department of Veterans Affairs Financial Services Center (FSC) P.O. Box 149971 Austin, TX 78714 Invoice shall be itemized to include the following information: Invoice number and date. Customer Number Payment terms 1.5/15 net 30 American Red Cross Tax ID Accounts receivable phone number Selling Unit Purchase Order Number Invoice Date Description of services performed, or products supplied. Quantity delivered and/or returned Unit cost billed. Credit Total Amount Fees charged by contractor shall be itemized as processing costs or blood services and are not charges for blood components. NOTE: PAYMENT OF INVOICES MAY BE DELAYED IF REQUIRED INFORMATION LISTED ABOVE AND IN FAR 52.212-4(g) IS NOT INCLUDED ON THE INVOICE. All incremental cost during the period of this agreement because of additional donor tests mandated by the state, federal agency, and industry practice, shall be the responsibility of the Atlanta VA Medical Center as long as Contractor provides thirty (30) days written notice of such cost, and a bilateral modification is executed by Contracting Officer. Payment may be retroactive to the 1st day after the 30th day written notification is provided by the Contractor. BLOOD COMPONENTS AND SERVICES: Upon receipt, Atlanta VA Medical Center shall promptly inspect the blood and maintain proper refrigeration or other proper storage facilities for the blood in compliance with all regulations, as well as the standards of the American Association of Blood Banks, as applicable. Atlanta VA Medical Center shall ensure that the blood, and any of its parts or derivatives, is not sold, bartered, traded or exchanged without Contractor s consent, except in the event of a life-threatening emergency. In the event of such an emergency, Atlanta VA Medical Center shall: Notify Contractor of the transfer after such transfer occurs. Track the transfusion recipient of the blood and notify Contractor as required in Work Statement paragraph 12. In the event Atlanta VA Medical Center uses the blood in a fashion that creates a need for human subject research protections, it is the responsibility of Atlanta VA Medical Center to ensure that such protections are provided including without limitation, human subject informed consent. NOTIFICATIONS: With respect to Contractor supplied blood, if a blood donor originally tests negative at the time of donation but then during a later donation, tests repeatedly reactive for the HIV antibody, the Contractor shall provide the Atlanta VA Medical Center with the results of follow-up testing required or recommended by the FDA. Contractor shall complete the follow-up testing within thirty (30) days after the donor s repeatedly reactive screening test. Under no circumstances shall Contractor ever reveal the identity of the blood donor. Contractor shall promptly notify Atlanta VA Medical Center when additional information indicates that blood provided may adversely affect transfusion recipient, provided that contractor shall not reveal the identity of the blood donor. Upon discovery, Atlanta VA Medical Center shall report to the contractor any blood lost or missing due to shipping error, and or possible infectious disease or other serious complication associated with transfusion which may have resulted from the blood, including without limitation, suspected post transfusion hepatitis, transfusion associated HIV or HTLV infection, and any other transfusion associated infections such as malaria, babesiosis, bacterial contamination or infection, and death due to adverse event. Atlanta VA Medical Center shall cooperate with contractor s investigation of any adverse event and provide information regarding recipient of blood, upon forms provided by contractor, to the extent permissible under the applicable regulations of patient confidentiality. BOOKS AND RECORDS: Atlanta VA Medical Center shall keep complete and accurate records of patients supplied with blood including product name, lot identifications and quantities, any therapeutic adverse effects, complaints and any pertinent information relating to the blood. NOTICES: All notices given or required in the contract shall be provided to each of the parties in writing and delivered by certified or registered U.S. first class mail, return receipt requested, or by recognized national overnight courier service which provides proof of delivery, to the names and addresses set forth in the signature block. Unless otherwise specified in this solicitation, all references to days are calendar and not business days. ENTIRE CONTRACT AND MODIFICATIONS: This solicitation and resulting contract are the entire agreement between the parties with respect to the supply of blood and services, and replaces all prior agreements and undertaking, both written and oral, between the parties with respect to the provision to the blood, blood components and services. CONFLICT OF INTEREST: The contractor shall not employ any person who is an employee of the United States Government if the employment shall create a conflict of interest. The contractor shall not employ any person who is an employee of the Department of Veterans Affairs unless such person seeks and receives approval in accordance with VA Regulations and public law. Nor shall the Contractor employ any person who is a member of the immediate family of a VA employee employed at Atlanta VA Medical Center, if the employment of that family member shall create a conflict of interest or the appearance of a conflict of interest, particularly regarding influencing the contract negotiations, terms of the contract or the work carried out under this contract. In any such case, Atlanta VA Medical Center must review the matter and provide approval in accordance with agency ethics regulations. POST AWARD PERFORMANCE CONFERENCE: The Contracting Officer shall schedule a post award performance conference with the Contractor if deemed necessary for contract orientation purposes. SITE SPECIFIC INSTRUCTIONS: Atlanta VAMC Decatur, GA. For reference laboratory services, STAT test shall be performed as a call in and reported within eight (8) hours of receipt of specimen. Routine request shall be reported the following business day. Complex reports shall be reported within seven (7) calendar days. Reports shall be submitted to the Atlanta VA Medical Center Blood Bank Supervisor or his / her designee. Autologous units collected by the contractor shall be shipped to Atlanta VA Medical Center blood bank within 5 days of collection. SPECIAL CONTRACT REQUIREMENTS: Note: Unless otherwise specified in this solicitation, the following applies to all VA Facilities participating in this contract: Bids shall be considered only from bidders whose blood bank is currently registered and or licensed with the Food and Drug Administration (FDA), Department of Human Services, pursuant to Section 510 of the Federal Food Drug and Cosmetic Act, 21 UCS Section 260, as amended. Offerors shall furnish copy of the license with offer. Bidders shall submit proof that he/she holds an unrevoked U.S. License which is issued by the Director, Bureau of Biologist, Food and Drug Administration (FDA) under Section 251 of the Public Health Service Act, as amended, 42 USC Section 262, as a source of supply for whole blood. (US License # ___________________________________________________) If interstate shipment of blood or blood components is involved, the bidder shall submit with his/her offer a statement that such approval has been authorized under Public Health Service Act 251, as amended 42, USC Section 262. The offeror shall possess a license to perform interstate laboratory testing services as required by the Clinical Laboratories Improvement Act of 1988. Licenses are issued by the Public Health Service, Health Care Finance Administration. Offerors shall furnish a copy of their license with their offer. The bidder certifies that he/she will comply with requirements outlined below with respect to donor s containers and deliveries. Offers will be considered only from blood banks who are able to provide the Department of Veterans Affairs with 100% volunteer donor blood in accordance with FDA rules and regulations, effective May 15, 1978 or later version. Volunteer donor is defined as: A person who does not receive monetary payment for blood donation. Benefits such as time off from work, membership in blood assurance programs, and cancellation on non-replacement fees that are not readily convertible to cash, do not constitute monetary payment. The Contractor shall be responsible for notifying the hospital of potentially HIV infected blood and blood components; the hospital will be responsible for patient notification. The Contracting Officer and/or his/her representative(s) reserve the right to inspect offerors facilities. The right is reserved to thoroughly inspect and investigate the establishment and facilities and other qualifications of any offeror, and to reject any offer regardless of price, if it should be administratively determined as lacking in any of the essentials necessary to assure acceptable standards of performance Criteria for Donor Selection, Donor Requirements: Offers will be considered only from blood banks which are able to provides the Atlanta VA Medical Center with 100% Volunteer donor blood in accordance with FDA rules and regulations effective May 15, 1978 or later revision. Definition of a volunteer donor is a person who does not receive monetary payment for blood donation. Benefits, such as time off from work, membership in blood assurance programs and cancellation or non-replacement fees that are not readily convertible to cash, do not constitute monetary payment. The offeror shall maintain blood donor lists including names, addresses, and social security numbers. Such lists should indicate whether and on what date blood of a donor was furnished to the Atlanta VA Medical Center under this contract. Donor selection must be in accordance with criteria established by the FDA and/or the American Association of Blood Banks (AABB). Collection Process and Typing of Blood: Blood will be typed for ABO and Rh antigens in accordance with methods recommended in the current editions of Standard for Blood Banks and Transfusion Service and Technical Methods and Procedures published by the AABB. Only HBsAG, NAT, HIV, HCV and HTLV I/II negative blood components will be accepted. All blood is to 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 maximum expiration for the preservative used. All blood supplies will be grossly free of hemolysis, excessive chyle and clots. Ordering: Formal purchase orders will not be written. Contractor will be notified of product requirements, as needed, by telephone, by the following authorized blood banks staff employees: Blood Bank Supervisor, Lead Blood Bank Medical Technologist, and Blood Bank Medical Technologists. Please see Attachment A for Requirements: See attached document: Attachment A.