6509--ARC Blood and Blood Products

The Department of Veterans Affairs, NCO 7, intends to award a sole source contract to The American Red Cross, 2751 Bull St, Columbia SC, 29230-3217. Requirement is to provide an alternative source for procurement of blood and blood products by Blood Bank, Pathology & Laboratory Medicine Service Charlie Norwood VA Medical Center, Augusta GA. This is a Firm-Fixed Pricing. Contract will include a base period and four (4) additional 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 Bruce Parrish, Contracting Officer at contact@example.gov. Phone number: +1 (555) 000-0000 Ext: 202342 by 1400 EST Feb 10, 2020 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 products by Blood Bank, Pathology & Laboratory Medicine Service, Charlie Norwood VA Medical Center, Augusta, GA. This is a Firm-Fixed Pricing. Background Charlie Norwood VA Medical Center (CNVAMC) in Augusta, Georgia must maintain an inventory of blood products and components that will sustain the transfusion needs of all patients within the facility. It is the mission of the Transfusion Medicine Service to provide cellular hemotherapy treatment for urgent care, surgical care, and medical care to patients in maintaining their homeostasis levels with a positive outcome. 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 long-term contract for blood and blood services, the contract includes base year and four (4) additional option year for a total of five years. Base year: April 1, 2020 March 31, 2021 Option year 1: April 01, 2021 March 31, 2022 Option year 2: April 01, 2022 March 31, 2023 Option year 3: April 01, 2023 March 31, 2024 Option year 4: April 01, 2024 March 31, 2025 Place of Performance: Charlie Norwood VA Medical Center, Pathology and Laboratory Medicine Service, Augusta, Georgia. The Contractor shall provide blood/blood products as available when ordered, and Charlie Norwood VA Medical Center shall purchase blood/blood products according to the appropriate fee schedule. The Contractor shall provide the applicable fee schedule with their proposal. 1. All blood and blood components provided to patients in the VA medical center must meet the requirements of the American Association of Blood Banks (AABB) and/or the Food and Drug Administration (FDA), Department of Health and Human Services. 2. Allogeneic blood/blood components must be typed for ABO and Rho(D) in accordance with licensed methodologies and must be tested for all transfusion transmitted disease markers currently required by both the FDA and AABB. a. All blood must be collected by the closed system under aseptic conditions, processed in appropriate solutions and the container so labeled. The label must also bear the expiration date of the contents, which must not exceed the Food and Drug Administration (FDA) allowable limit for the type of anticoagulant in which the blood component is drawn. b. All blood supplied must be free of hemolysis, clots, and excessive chyle based on the contractor s visual inspection of such blood prior to delivery. 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 Charlie Norwood VA Medical Center, the Contractor shall ship products to Charlie Norwood 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 Charlie Norwood VA Medical Center Blood Bank within 6 hour for STAT orders and 3 hours for ROUTINE orders from the time the order is placed with the contractor. c. All blood supplied must have at least 3 segments attached to the RBC unit at the time of delivery. 3. Autologous blood/blood components must be typed for ABO and Rho(D) in accordance with licensed methodologies and must be tested for all transfusion transmitted disease markers currently required by the FDA. 4. The Contractor shall supply 100% volunteer donor blood as defined in 21CFR606.121(c)(5)(ii). All blood/blood components must be collected from donors in accordance with the requirements of the AABB and the FDA. 5. In the event of a recall or market withdrawal, the Contractor shall promptly send copies of the recall or market withdrawal request to the Blood Bank Medical Director at the VA medical center where the blood product was issued. 6. The Contractor awarded to this contract shall be the primary source for blood and blood components to maintain maximum stock inventories, rare donor requests, and the secondary source to complete urgent requests and autologous donor blood. The Facilities shall obtain blood and blood components from a provider other than the awarded Contractor when: (i) There is an emergent circumstance (as defined in the Facilities reasonable discretion, with an explanation to be provided to the Contractor if requested); or (ii) There is a Force Majeure Event (as provided herein); or (iii) The Contractor is unable to provide blood or blood components within a reasonable time of an order being placed; orn (iv) The Contractor refuses to provide blood or blood components; or (v) At the request or direction of a patient or a patient s physician, the facility is directed to use autologous blood or homologous blood and type specific components which is available through a provider other than the awarded contractor B. Changes in Testing Requirements for Transfusion Transmitted Diseases In the event that additional testing for transfusion transmitted diseases is nationally mandated by the FDA during the contract period, specific price adjustments may be requested by the supplier to address the cost for the additional testing. In the event that this should occur, a letter detailing the rationale for the price increase must be submitted to the Contracting Officer at least 30 days before the intended implementation date. C. Donor Requirements 1. Offeror s donor identification numbers must be unique to the donor unit and must have an FDA-approved numbering schematic. 2. Donor selection must be in accordance with criteria established by the FDA and/or the AABB. 3. Each unit of blood collected through voluntary donation must minimally be tested for all transfusion transmitted disease markers currently required by both the FDA and AABB. 4. Each platelet component must be tested for bacterial contamination (sterility) in accordance with current AABB standards. 5. Donors who have a positive antibody screen or positive direct antiglobulin test will not be accepted for transfusion of their red blood cells. The Unit will be returned to the contractor for credit and a replacement unit will be requested. 6. Red Blood Cells with less than 14 days and Frozen plasma and Cryoprecipitate with less than six months of viability/expiration will be credited if not transfused due to the component s shortened shelf life unless it has been agreed upon by the VA transfusion service supervisor to accept them. B. Supplies: Orders/Deliveries a. Contractor is to deliver all Routine and Stat orders accordingly as follows: - Routine shipments of blood products are to arrive on the same day before 2 pm for orders entered electronically before 10 AM. After 10 AM, all orders entered electronically are to be shipped within six hours. All autologous shipments are to arrive before 2 PM the day preceding the patient s surgery date. -Stat shipments of blood products are to arrive within 90 minutes of the time that the online order was placed. b. The Contractor must contact the Blood Bank Technologist or Supervisor by phone when the orders will not arrive on time or when the products are unavailable. c. The Contractor shall make delivery services for blood and blood components available 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). d. Routinely ordered products will include but not be limited to leukoreduced, irradiated, or antigen negative red blood cells, frozen plasma, platelet pheresis, radiated platelet pheresis, autologous red blood cells, cryoprecipitate (cryo) and specialized products including crossmatched platelet pheresis, HLA platelet pheresis, and rare donor typed units. C. VA responsibilities: a. Blood Bank Technologist will be subject to and comply with all requirements and regulations associated with the recall and withdrawal of blood and blood components from its inventory due to health and safety risks. b. Blood Bank Technologist will assist the contractor and other facilities in meeting patient transfusion needs by transferring blood products from the VA inventory to the contractor and receiving credit for each product transferred. c. Charlie Norwood VA Transfusion Service personnel are the only authorized staff to place orders and receive shipments from the Contractor. Please see Attachment A for Requirements: