The Department of Veterans Affairs, VISN 7, intends to award a sole source contract to The American Red Cross, Gulf Coast Region, PO Box 73914, Chicago, IL 60673-7914, DUNS Number 087564295. Requirement is to provide an alternative source for procurement of blood and blood products by Blood Bank, Pathology & Laboratory Medicine Service, Central Alabama Veterans Health Care System (CAVHCS). This is an Indefinite Delivery, Indefinite Quantity (IDIQ) contract with 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 Joseph M. Locke, Contracting Officer at
[email protected] NLT August 20, 2021 at 10am EST. 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. CENTRAL ALABAMA VETERANS HEALTH CARE SYSTEM Pathology and Laboratory Medicine Service Montgomery/Tuskegee, Alabama STATEMENT OF WORK BLOOD AND BLOOD PRODUCTS 619-22-1-7313-0001 GENERAL INFORMATION: The Contractor shall provide Blood and Blood Products to Central Alabama Veterans Health Care System, for Blood Bank, Pathology and Laboratory Medicine Service, 215 Perry Hill Road Montgomery, Alabama 36109, in such quantities and at such times as may be required in accordance with all terms, conditions, provisions and the schedule herein. ESTIMATED BLOOD PRODUCT QUANTITIES NEEDED: Estimates of needed quantities are as accurate as possible utilizing current and projected workload information. ESTIMATED BLOOD PRODUCTS QUANTITIES ITEM NO. DESCRIPTION BASE ESTIMATED QTY 1ST OPTION YEAR 2ND OPTION YEAR 3RD OPTION YEAR 4TH OPTION YEAR 1 Red Blood Cells Leuko-reduced 450 Units 450 Units 500 Units 500 Units 550 Units 2 Fresh Frozen Plasma 24 35 Units 35 Units 45 Units 45 Units 50 Units 3 Plateletpheresis 45 Units 50 Units 55 Units 55 Units 60 Units 4 Non-routine deliveries, Leuko-reduced (subject to fuel charges) 35 EA 35 EA 35 EA 35 EA 35 EA 5 Routine Antibody Screen ID 50 EA 55 EA 55 EA 60 EA 60 EA PERFORMANCE PERIOD The performance period will be one year from the date of award plus four (4) one-year options that may be exercised by CAVHCS. Performance Period: Base Period: October 1, 2021 to May 31, 2022 Option Year 1: June 1, 2022 to May 31, 2023 Option Year 2: June 1, 2023 to May 31, 2024 Option Year 3: June 1, 2024 to May 31, 2025 The Contract is subject to the availability of funds. The Contractor shall perform no services after September 30 of any year until the Contracting Officer authorizes such services in writing. TYPE OF CONTRACT: The contract will be an indefinite delivery quantity contract with firm-fixed price delivery of orders placed against it. PAYMENT TERMS: NET 30 Days after the receipt of a bill of collection. Payment will be made upon receipt of a properly prepared detailed invoice prepared by the Contractor, validated by the COTR, and submitted to VA FSC, P.O. Box 14991, Austin, TX 78714. A properly prepared invoice shall contain: Invoice Number and Date Contractor s Name and Address Accurate Purchase Order Number Supply or Service provided Quantity Invoices must contain actual dates of service Total Amount Due QUALITY OF THE PRODUCT All whole blood and blood components provided to patients in VA medical centers 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. 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. 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. All blood supplied must be free of hemolysis, clots, and excessive chyle. 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. 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. In the event of a recall, Contractor shall promptly send copies of the recall request to the Blood Bank Medical Director at the VA medical center where the blood product was issued. Contractor shall have reference transfusion services available to CAVHCS. The offeror must be capable of providing the blood components and specialized testing detailed in the Schedule of Supplies/Services and Prices/Costs (the Schedule) on a 24-hour per day, seven days per week basis. The Contractor awarded this contract shall be CAVHCS s primary supply source for blood and blood components. The Facilities shall obtain blood and blood components from a provider other than the awarded Contractor only if: There is an emergent circumstance (as defined in the Facilities reasonable discretion, with an explanation to be provided to the Contractor if requested); or There is a Force Majeure Event (as provided herein); or The Contractor is unable to provide blood or blood components within a reasonable time of an order being placed; or The Contractor refuses to provide blood or blood components; or At the request or direction of a patient or a patient s physician, the facility is directed to use autologous blood which is available through a provider other than the awarded contractor CHANGES IN TESTING REQUIREMENTS FOR TRANSFUSION TRANSMITTED DISEASES In the event 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 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. DONOR REQUIREMENTS The contractor shall maintain readily available blood donor lists, including names, addresses, and social security numbers. Such lists must indicate whether, and on what date, blood of a particular donor was furnished to CAVHCS under this contract. Offeror s donor identification numbers must be unique to the donor unit and must have a FDA-approved numbering schematic. Donor selection must be in accordance with criteria established by the FDA and/or the AABB. 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. Each platelet component must be tested for bacterial contamination (sterility) in accordance with AABB standard 5.1.5. effective March 1, 2004. ORDERS/DELIVERIES Orders will be categorized into three types: routine, as soon as possible (ASAP) and STAT. These categories are defined as follows: Routine-Shipments of blood products to maintain minimum inventory levels or blood products ordered to fulfill a standing request. As Soon As Possible (ASAP) Shipments of blood products to fill a request for a waiting outpatient, or a non-life-threatening need within several hours, 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 of request. STAT A need for blood products so acute that a patient s life could be jeopardized if the request for blood products is unfulfilled. STAT orders must be delivered within 90 minutes of request to all sites. Routine blood and blood component orders shall be delivered as specified within 24 hours following online, telephoned, or faxed orders or mutually agreed upon shipment of inventory. All online orders shall be followed up with a confirmation e-mail for facilities that use online orders. Telephone orders shall be confirmed at time of order. To facilitate service to the Facilities, the contractor shall maintain service 24 hours a day, seven days a week. Contractor shall make delivery services for blood and blood components available to all VA sites 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). Unless other arrangements are made, the contractor shall pay expenses for delivery of blood and blood components to and from each hospital using the method of delivery or shipment appropriate to the circumstances. Contractor will ensure that all blood and blood components supplied to the Facilities will be accompanied by appropriate documentation and will be transported in a validated manner to ensure that the blood and blood components remain within specification throughout the transfer period. Thereafter, the Facilities shall be responsible for any loss, destruction, or damage to the blood. The blood components provided to the Facilities may not be sold, exchanged, transferred without the prior authorization of the Contractor, except in the event of an emergency. The Facilities shall notify the Contractor in the event of such an emergency and retain records to track the disposition of the unit. a) The routine standing delivery schedule will be two (2) deliveries per week (Monday-Friday). b) It is estimated that ASAP delivery services will occur thirty-five (35) deliveries each year. c) It is estimated that STAT delivery services will occur ten (10) deliveries each year. The specific volumes distributed in a routine order will be established by CAVHCS. However, the contractor shall submit a proposed delivery and route schedule for approval within ten days after contract award. Schedule may be adjusted periodically. Either leuko-reduced or non-leuko-reduced blood will be ordered. Once units are received by a VA medical center, those units become the property of the VA medical center, and payment will be made appropriately, based on contract terms and proper invoicing. They are not to be treated as though they are on consignment. However, for inventory control purposes, efforts will be made by each VA medical center to assist the contractor and other facilities in meeting patient transfusion needs. The VA will be subject to and comply with all requirements and regulations associated with the recall and withdrawal of blood or blood components from its inventory due to health and safety risks. Efforts will be made to assist the supplier in hosting blood donor drives at the VA medical center(s) in those cases where it can be reasonably accommodated by the hosting VA site, and where there are no previous commitments to other blood centers, including the Department of Defense. The annual number of blood donor drives will be negotiated between the contractor and the VA medical center. LABORATORY TESTS: All laboratory tests must be performed by a laboratory accredited by AABB, certified by HCFA, or licensed and/or registered by FDA. In the event the vendor implements a new laboratory test intended to improve the safety or quality of blood or blood components provided to the Facilities and as required by FDA or as advisable pursuant to professional standards including standards or recommendations through the AABB or other professional organizations, the contract may be modified at the discretion of the Government to add the test to the price schedule. VA PERSONNEL AUTHORIZED TO PLACE ORDERS: CAVHCS VA personnel authorized to place orders will be identified at time of award SHELF LIFE All blood/blood components must be labeled, stored, and shipped in accordance with the current regulations of both the FDA and the AABB. In the event these regulations change during the course of the contract, the contractor shall implement the necessary changes as directed/recommended by the regulatory and accrediting agencies. For routine orders, allogeneic blood/blood components must be supplied with appropriate remaining shelf life, as detailed below. Allogeneic blood/blood components Appropriate Remaining Shelf Life Whole Blood Shelf life more than 21 days, regardless of anti-coagulant Red Blood Cells Shelf life more than 21 days, regardless of anti-coagulant Fresh Frozen Plasma Shelf life more than 60 days Platelets (random) Shelf life more than 48 hours Plateletpheresis Shelf life more than 48 hours, if not ordered/collected for a specific patient Cryoprecipitate Shelf life more than 60 days For ASAP and STAT orders, the contractor shall provide units with the appropriate remaining shelf life IAW E.2 whenever possible; however, CAVHCS understands that the urgency of the situation and the availability of the blood product may preclude this possibility. 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 Schedule. VALUE ADDED SERVICES These services will be provided to CAVHCS at no charge. Contractor shall provide physician consultative services to CAVHCS that are consistent with the services offered to other non-VA contracted customers. A description of the services must be included with the offeror s proposal. Contractor shall provide educational programs to CAVHCS that are consistent with the programs offered to other non-VA contracted customers. A description of the educational programs must be included with the offeror s proposal. QUALITY CONTROL PROGRAM Performance standards define desired services. The Government performs surveillance to determine Contractor and Contract exceeds, meets or does not meet the Performance Standards identified below. The Government reserves the right to monitor all aspects of Contractor performance as it pertains to the terms and conditions stated herein. Performance Standards: Contractor shall maintain current licensure in the field of Blood and autologous blood. Contractor shall ensure proper temperature of blood products during shipping and storage. Contractor shall adhere to schedule as outlined. Contractor shall ensure appropriate labeling of blood and blood products. Methods of Quality Control Surveillance: Various methods exist to monitor performance. The Contracting Officer s Technical Representative (COTR) shall use the surveillance methods listed below in the administration of the Quality Control Program. Direct observation performed periodically through the life of the Contract. Periodic inspection evaluates outcomes on a periodic basis. Inspections may be scheduled or unscheduled as required. User survey combines elements of validated user complaints and random sampling. Random survey is conducted to solicit user satisfaction and may lead to sampling and inspections. Period sampling variation of random sampling. However, sample is only taken when problem/deficiency is suspected. Sample results are applicable only for the specific work inspected. Since sample is not entirely random, it cannot be applied to total activity performance. Security: This requirement is for blood and blood products only the C&A requirements do not apply. Security Accreditation Package is not required. Documenting of Quality Control Surveillance: The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action. Negative findings will be provided to Contracting Officer for resolution with Contractor. Quality Assurance Plan Tasks ID Indicator Standard Acceptable Quality Level (AQL) Method of Surveillance Meeting Turnaround Times 1 Provide timely non-local product delivery. Product shall be shipped to VAMC by overnight courier. Products ordered by 02:00 pm, Mon-Fri shall be shipped by air for delivery by the following day. 90% Observation and Audit 2 Provide timely local product delivery. Products shall be delivered to the VAMC Blood Bank within 1 hour for STAT orders and within 4 hours for Routine orders from the time the order is placed. 90% Delivery and Inspection 1 Packaging and Marking/Labeling Blood components shall be labeled IAW all FDA requirements. 100% Observation and Audit 2 Shipping and Transport FDA required temperature ranges are maintained: red cell components (1-10 C); frozen plasma components (below minus 20 C); platelet components (20-24 C) 95% 3 Component Inspection All blood products shall be free of hemolysis and clots. 90% Observation and Audit Certifications 1 Provide licensing As requested by using service line 100% 2 Provide accreditation Before contract award