Inactive

Unrestricted Blood Bank Products - BHH

Inactive

This is a Pre-Solicitation notice for the Department of Veterans Affairs, Network Contracting Office 23, for the procurement of Blood Bank Products & Services at the Black Hills VA Health Care System ... This is a Pre-Solicitation notice for the Department of Veterans Affairs, Network Contracting Office 23, for the procurement of Blood Bank Products & Services at the Black Hills VA Health Care System located in Fort Meade, SD. The NAICS code for this procurement is 621991 Blood and Organ Banks with a size standard of $40 Million. Potential offerors are responsible for monitoring this site for the release of the solicitation package and any other pertinent information and for downloading their own copy of the solicitation package. Any amendments issued to this solicitation will ONLY be available on this site. Offerors are advised that they are responsible for obtaining all amendments. All questions must be submitted in writing to the Contracting Officer at joseph.bloomer@va.gov. No telephone inquiries will be accepted. This notice does not obligate the Government to award a contract neither does it obligate the Government to pay for any quotes or proposal preparation costs. The Government is not obligated to issue a solicitation as a result of this notice. No other information is available until issuance of the solicitation. All interested parties must be registered in System for Award Management (SAM) to be eligible for award. Registration information can be found at www.sam.gov. 1. Background: 1.1. Intent: The Department of Veterans Affairs, Fort Meade Black Hills Health Care System BHHCS Heath Care System, (herein afterwards referred to as VHABHHCS) is requesting an Indefinite Delivery Indefinite Quantity Contract for BLOOD BANK. The Government will award a CPRR IDIQ to a single Contractor for BLOOD BANK. Contractor agrees to the following terms of the IDIQ exclusively with the BHHCS facility listed by Attachment/herein and awarded in the final IDIQ. However, as requirements change, facilities within BHHCS may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests/reagents/instrumentation may be added to the IDIQ as new technology becomes available on the market. Ordering Period 1: 10/1/25-9/30/26 Ordering Period 2: 10/1/26-9/30/27 Ordering Period 3: 10/1/27-9/30/28 Ordering Period 4: 10/1/28-9/30/29 Ordering Period 5: 10/1/29-9/30/30 1.2. Orders: This IDIQ does not obligate any funds. The Government is obligated only to the extent of authorized orders issued under the IDIQ by authorized individuals. 1.3. Prices and Terms: VHABHHCS will provide an estimated volume by test as reflected in Attachment A for the medical center. Pricing is based on the AVERAGE daily test volume. The Government estimates the volume as listed in the Price/Cost Schedule but does not guarantee volumes as listed; they are estimates ONLY. 1.4. Term Of Agreement: This will be a single award, firm-fixed price IDIQ with Five Ordering Periods. If the Contractor fails to perform in a manner satisfactory to the CO, this IDIQ may be canceled with thirty (30) days written notice to the Contractor by the CO. This IDIQ shall be reviewed annually. VISN 23 intends to establish the first ordering period of the agreement for the period of Award date through twelve months. 1.5. Identification: Delivery Orders issued shall be identified by their applicable IDIQ Contract Number. 1.5. Ordering Method: The facility may order products via Electronic Data Interchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions. 2. Description/Specifications/Statement of Work: 1. All whole blood and blood components provide to patients in VA medical centers must meet the requirements of the American Association of Blood Banks (AABB), the Food and Drug Administration (FDA), and Department of Health and Human Services. 3. Contractor Responsibilities Quality of the Product 1. All whole blood and blood components provided to patients in VA medical centers shall meet the requirements of the American Association of Blood Banks (AABB), the Food and Drug Administration (FDA), and Department of Health and Human Services. 2. Allogeneic blood/blood components shall be typed for ABO and Rho(D) in accordance with licensed methodologies and shall be tested for all transfusion transmitted disease markers currently required by both the FDA and AABB. a. All blood shall be collected by the closed system under aseptic conditions, processed in appropriate solutions and the container so labeled. The label shall 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 shall be free of hemolysis, clots, and excessive chyle. 3. The Contractor shall supply 100% ''volunteer donor" blood as defined in-21CFR606.12l(c)(5)(ii). All blood/blood components shall be collected from donors in accordance with the requirements of the AABB and the FDA. 4. 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. 5. Contractor shall refer/make referral transfusion services available as outlined in the schedule of services. 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. B. Changes in Testing Requirements for Transfusion Transmitted Diseases If 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. The contractor shall maintain readily available blood donor lists, including names, addresses, and date of birth. Such lists must indicate whether, and on what date, blood of a particular donor was furnished to the VA under this contract. 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 infectious diseases as outline by regulatory agencies. 4. Each platelet component must be tested for bacterial contamination in accordance with AABB standards. D. Orders/Deliveries 1. Orders will be categorized into three types: Routine, As Soon As Possible and STAT. These categories are defined as follows: a. Routine-Shipments of blood products to maintain minimum inventory levels or blood products ordered to fulfill a standing request. b. 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 3 hours. c. 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 2 hours. 2. Contractor shall make delivery services for blood and blood components available to the VABHHCS Health Care System Medical Center 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). Fort Meade VA Medical Center 113 Comanche Road Fort Meade, SD 57741 3. All blood products delivered under this contract shall be properly packaged and insulated in such a way as to ensure that a proper temperature appropriate for the product is maintained during transport between contractor's place of business and the VA Medical Center. The contractor will meet all federal and state DOT requirements for transportation of human blood and blood products. 4. Routine orders shall be placed shall be placed as agreed. STAT and ASAP orders shall be placed utilizing a direct line telephone system. 5. Once units are received by the 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 the VA medical center to assist the contractor and other facilities in meeting patient transfusion needs. 6. The VA will 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. E. Shelf Life 1. 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 that 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. 2. For routine orders, allogeneic blood/blood components must be supplied with appropriate remaining shelf life, as detailed below. Allogeneic blood/blood components Appropriate Remain in Shelf Life Red Blood Cells Shelf life more than 14 days, regardless of anti-coagulant Thawed Fresh Frozen Plasma Shelf life more than 60 days Plateletpheresis Platelets Stored at Contractor's facility until date of transfusion: remaining shelf life 1 day. Cryoprecipitate Shelf life more than 60 days 3. For ASAP and STAT orders, the contractor shall provide units with the appropriate remaining shelf life whenever possible, however, the VA understands that the urgency of the situation and the availability of the blood product may preclude this possibility. 4. 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. F. Services 1. Contractor shall provide physician and medical technologist consultative services to the VA BHHCS that are consistent with the services offered to other non-VA contracted customers. These services shall include telephone consultative assistance to VA BHHCS blood bank laboratory staff for testing performed on site by the VA, antigen typing donor units for transfusion, antibody identification, and direct antiglobulin tests. A description of the services must be included with the offeror's proposal. This assistance must be available on a 24/7 basis. 2. Contractor shall provide educational programs to the BHHCS 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. 3. Contractor shall provide storage of platelets at their facility until needed for transfusion. 4. Direct communication with the vendor through email or telephone to place orders is acceptable. All blood product orders to the vendor must have a mechanism to document and communicate with BHHCS when the vendor received the order and date and time the blood products is sent from the vendor (in transit). Email status updates to key VABHHCS personnel are acceptable. BHHCS documents the date and time the blood products are received at our facility, but the vendor may want to document delivery date and time as well. G. Security 1, ACCESS TO PATIENT INFORMATION: In performance of official duties, Contractor's Provider(s) and Technologist(s) may have regular access to printed information containing sensitive data, which must be protected under the provisions of the Privacy Act of 1974 (5 U.S.C. 552a), and other applicable laws, Federal Regulations, Veterans Affairs statutes and policies. Contractor's Provider(s) and Technologist(s) are responsible for (1) protecting that data from unauthorized release or from loss, alteration, or unauthorized deletion. a. Contractor staff shall complete required information security training: Privacy and HIPPA (VA 10203) and VA Privacy and Information Security Awareness and Rules of Behavior (VA I 0176). Security Training will be accomplished annually. Contractor staff shall select training modules for Privacy Training and Information Security Training. Upon completion of the training, please email or fax training certificates to the Contracting Officer Representative. H. 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. BLOOD GROUP: ABO Blood group plus the Rho(D) type of the unit, specifically O+, 0-, A+, A-, B+, 8-, 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 is 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. CRYOPRECIPIT ATE: 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. THAWED 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. PLATELETAPHERESIS: 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: Platelet component that is prepared from a pool of platelet donations from approximately six units 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. Provides similar quantity of platelets as Plateletpheresis but is not derived from a single donor and does not have the advantage of minimizing donor exposures to prevent the patient from becoming refractory and/or contracting a transfusion transmitted disease. 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. ROUTINE ORDERS: Orders that are generally placed on a regular basis at a pre-established time to provide adequate inventory of specific blood components of specific blood groups. SHELF LIFE: Number of days remaining prior to the expiration date from the date received in the facility. SPECIAL TYPINGS: Typing for RBC antigens other than ABO and Rho(D); performed in order to find red blood cell units appropriate for patients who have developed unexpected antibodies. STANDING ORDER: A type of routine order which allows for shipment of a specific volume of specific blood components according to an established delivery schedule; assists the supplier in projecting volumes of components required to improve recruitment and minimize waste. VOLUNTEER DONOR: 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.