Inactive

This Notice of Intent to Sole Source is provided to advise that the Government intends to solicit and negotiate a Sole Source, Firm-Fixed-Priced, Purchase Order, with only one (1) source, within a 30 ... This Notice of Intent to Sole Source is provided to advise that the Government intends to solicit and negotiate a Sole Source, Firm-Fixed-Priced, Purchase Order, with only one (1) source, within a 30 Mile Radius to ensure a one delivery. The procurement is for the Transfusion Services and Blood Products for the Fargo VA Health Care System. This contract action is for supplies for which the Government intends to solicit and negotiate with only one (1) source under the authority of FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; will meet the Government s needs. The applicable NAICS Code is 621991 and the 2022 size standard is $40 Million. DRAFT Statement of Work INTENT: It is the intent of the Fargo VA Health Care System Pathology & Laboratory Medicine Service (P&LMS) identified below to establish an agreement for blood, blood components, and reference testing for their patient population. These components/supplies shall be provided per the Independent Government Estimate provided in the Statement of Work for each facility. PERIOD OF PERFORMANCE: This will be a base + 4-year IDIQ contract from 10/1/2025 through 9/30/2030. Base Year: 10/01/2025 09/30/2026 Option Year 1: 10/01/2026 09/30/2027 Option Year 2: 10/01/2027 09/30/2028 Option Year 3: 10/01/2028 09/30/2029 Option Year 4: 10/01/2029 09/30/2030 PRICING SCHEDULE: Pricing shall be based on the list of products listed in Attachment A Blood and Blood Component Products and Estimated Volumes and Reference Services listed in with estimated volumes. The Government estimates the volumes per facility but does not guarantee volumes; they are ESTIMATES ONLY. SCOPE OF PROCUREMENT: The Contractor shall provide all labor, materials, supervision, and transportation and any incidentals necessary for the successful performance of this SOW. All blood and blood components provided to patients at The Fargo Veterans Affairs Health Care System must meet the requirements of the American Association of Blood Banks (AABB) and/or the Food and Drug Administration (FDA). The contractor agrees to comply fully with pertinent FDA/AABB applicable requirements concerning the recruitment of donors, collection, testing, labeling, storage, packing and shipping of blood components. All blood supplied shall be from volunteer donors in accordance with AABB and FDA rules and regulations. All blood components received from the contractor shall be leukoreduced. 1.2 Contractor shall notify the P&LMS in as timely a manner as is feasible when information subsequently becomes available to indicate that a blood component or related service has been provided which, based upon new information, may deleteriously affect a transfusion recipient. Contractor shall notify the VA facility in a timely manner, about blood components forwarded to the medical center for which there may be an increased risk of transmission of HIV and provide confirmatory test results when they are available. As required by 42 CFR, 482.27, the contractor shall notify the VA facility of the following: If required by law, 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 HIV and/or HCV antibody, then the contractor shall provide the VA with results of the follow-up testing as required or recommended by the FDA. The contractor shall complete the follow-up testing notification within forty-five (45) days after the donor s repeatedly reactive screening test. The Contractor shall provide the requirements, special collection forms and the collection of autologous and directed donor units at their collection centers for the purposed facilities. Contractor shall make reference transfusion services available to the Fargo VA. 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. Since the Fargo VA operates 24 hours per day, 7 days per week, 365 days per year the contractor shall be required, upon contract award, to provide toll free telephone numbers and/or online services for contacting the Contractor s local facility and/or satellite facilities, reference laboratory and the distribution /hospital services for dayshift and after-hours coverage. After hours coverage is to include any time the Contractor s facility does not have an individual stationed at their facility such as after routine business hours, weekends and/or holidays. The Contractor shall be responsible for guaranteeing the telephone numbers and/or online services stay current and updated at all times. The Contractor shall make every reasonable effort to provide services set forth in Attachment A, regarding blood and diagnostic testing laboratory services for both emergency and non-emergency testing during normal business hours (8:00am 4:00pm) 365 days a year, seven (7) days per week, to include holidays. Due to the need for occasional after-hours testing for the Fargo P&LMS, the Contractor shall make every reasonable effort to support emergency testing for scenarios such as, but not limited to, a) Patient actively bleeding, b) Emergency surgery, c) Symptomatic anemia, d) Emergency red cell exchange, e) Recent medical history that could be adversely impacted by development or worsening of anemia, f) etc. 365 days a year, seven (7) days a week, to include holidays. Outpatient transfusion (stable patient), Elective surgery (antibody ID or requests for antigen negative blood), Transfusion not emergent and patient s condition unlikely to change for several hours, etc., but not limited to these scenarios, are not considered emergencies for afterhours testing. The P&LMS understands and agrees that depending upon the complexity of the patient s blood sample, the time involved for testing resolution may range from several hours to several days. The Contractor shall be responsible for the packaging of products for return. Fargo P&LMS shall promptly inspect all shipments upon arrival and report any actual or suspected damage, irregularity, testing or labeling error. The contractor will make every effort to promptly replace the affected blood product, or the contractor shall issue credit and explain how their credit is reflected on an invoice for all products Transferred/Returned per the following return policy/procedures: Any product that arrives at the facility in a broken/damaged container (not intact) shall be promptly replaced or returned for 100% credit. This is to include any frozen product where the broken and/or cracked unit is not discovered until it is thawed. Any product that arrives outside of acceptable regulated/accredited temperature ranges shall be promptly replaced or returned for credit Any product found to have testing or labeling errors shall be promptly replaced or returned for credit. The Contractor shall provide a list of their product codes to determine the compatibility with the P&LMS s blood bank computer system. The Contractor will assist the facilities in analyzing their blood and blood components usage during the first thirty (30) days of the contract and annually thereafter. The Contractor may suggest measures to reduce wastage of blood products and/or reduce the number of STAT orders by adjusting stock or accepting products returns prior to expiration dates. The Contractor shall be the primary supply source for blood and blood components as well as routine blood related reference laboratory services. The facility will obtain blood and blood components and services from another provider 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. TESTING REQUIREMENTS: Laboratory Tests: All laboratory tests must be performed by a laboratory accredited by AABB and licensed and/or registered by FDA. This is an AABB standard therefore proof of accreditation/certification/license shall be submitted with offer and annually thereafter. 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 Fargo P&LMS to add the test to the price schedule. The Contractor shall employ pathogen reduction technology to control the risk of bacterial contamination of room temperature stored platelets or test for bacterial contamination consistent with the AABB and FDA s recommendations and provide immediate notifications (24 hours per day, 7 days per week) to the facility via phone if a platelet unit were to test positive for contamination as this could be detrimental to the patient that receives the product. The Contractor shall state current method of testing for bacterial contamination. Testing of donor blood shall follow all recommendations by both AABB and FDA. Allogeneic blood/blood components must be typed for ABO and Rho(D), and detection of unexpected antibodies to red cell antigens, and must be tested for all transfusion transmitted disease markers currently required by both the FDA and AABB. The method for platelet procurement must follow AABB current guidelines. All blood must be labeled according to the ISBT 128 labeling standard. The reagents used for required tests on blood samples shall meet applicable FDA and AABB regulations. Additional testing and/or follow-up testing may be implemented as the need arises or as required by the FDA and/or per AABB standards. Testing, to prevent disease transmission, shall be negative except for Autologous blood. The Contractor shall provide their plan for Transfusion-Related Acute Lung Injury (TRALI) mitigation. 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. HANDLING: The Contractor shall be responsible for transporting and storing blood components (frozen, room temperature and refrigerated) and specimens in such a manner as to ensure the integrity of the product or specimen. The contractor shall annually provide evidence of their verification of the Temperature Monitoring process used for the storage and transportation of products. The Contractor shall state the frequency of the temperature validation for the transportation of products, type of coolant material used (i.e. wet ice), and how many pounds of coolant material is required per unit of product. The Contractor shall ensure that all blood and blood components (frozen, room temperature and refrigerated) shall be processed, stored, and transported according to FDA and AABB regulations. It shall be collected in a closed system under aseptic conditions. It shall be processed in appropriate solutions. The container shall be labeled in accordance with regulations. Additionally, all blood supplied shall be free of gross hemolysis, lipemia and/or clots. DELIVERY REQUIREMENTS: 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 60 minutes. Contractor shall make delivery services for blood and blood components available to the Fargo VA HCS 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). It is estimated that Routine delivery services will occur at the following estimated rate: 0-2 deliveries/day It is estimated that ASAP delivery services will occur at the following estimated rate: 0-2 deliveries/day It is estimated that STAT delivery services will occur at the following estimated rate: 0-2 deliveries/day Once units are received by the Fargo VA HCS, those units become the property of the VA HCS, 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 HCS to assist the contractor and other facilities in meeting patient transfusion needs. 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. Any qualified and authorized personnel working in the facilities Blood Bank may request blood and/or blood components from the Contractor s facility by telephone or electronic ordering 24 hours per day, 7 days per week, 365 days per year. Blood products shall be supplied as fresh as possible to minimize losses due to outdating. Red blood cells shall be returned to the offeror s facility for credit when the units are within 7 calendar days of expiration. Shelf Life: 4.7.2 For routine orders, allogeneic blood/blood products shall be supplied as fresh as possible to minimize losses due to outdating. Red blood cells shall be returned to the offeror s facility for credit when the units are within the offerors return policy. The offeror shall supply an outline of appropriate shelf life for products sent as well as criteria for return to the offeror if not used within a specified time from outdate. 4.7.3 Allogeneic blood/blood components Appropriate Remaining Shelf Life Red Blood Cells Information to be supplied by offeror Fresh Frozen Plasma Information to be supplied by offeror Plateletpheresis Information to be supplied by offeror Cryoprecipitate Information to be supplied by offeror 4.8 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. 5.0 REFERENCE TESTING SERVICES: In addition to supplying blood products, the vendor shall perform reference testing as outlined in attachment A. Upon award the contractor will provide a turnaround time for these tests. **Preliminary case resolution shall be communicated within 12 hours. Final resolution of each serological case is dependent on the case complexity. Value Added Services 5.1.1 Contractor shall provide physician consultative services to the Fargo P&LMS 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. 5.1.2 Contractor shall provide educational programs to the Fargo P&LMS 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. ACCREDITATION/CERTIFICATION/TRAINING REQUIREMENTS: 6.1 Business Associate Agreement (BAA) The Contractor is to provide their BAA. A business associate is an entity including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receive, use, or disclose VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule. The Contractor shall possess and maintain all licenses, permits, accreditation and certificates required by local, state, and federal laws to include requirements, regulations, recommendations, standards, specifications, guidelines, and directives of the FDA, the U.S. Public Health Service, AABB, and The Joint Commission (TJC). In the event of any conflict between any regulations, U.S. law shall govern. The Contractor shall ensure that all contract personnel (Technologists, Technicians, and Couriers) have appropriate certification/licenses and annual HIPAA compliant training required by the state or the accreditation agencies of the contractor (such as current and valid licenses and/or certifications). SUBCONTRACTORS: If a subcontractor is to be utilized by the Contractor, the subcontractor and their subcontracting plan must be approved by the Contracting Officer prior to performance under this contract. The Contractor shall be responsible for finding an outside laboratory with appropriate licensure and accreditation to perform tests that the contractor cannot perform. The Contractor shall notify the VA Laboratory and Contracting Officer of any change of subcontract. Any changes shall be submitted to the Contracting Officer in writing for review and approval. GOVERNMANT SITES: When the Contractor personnel enter upon Government grounds, they shall adhere to the following policies: The contracted personnel must have an identification (ID) badge from the Contractor. The ID badge is to be worn at all times and is to be displayed above the waist when entering each facility. It is the responsibility of Contractor personnel to park only in designated parking areas. Parking information is available from the VA Police Service. The VA will not invalidate or make reimbursement for parking violations of the Contractor s personnel under any circumstances. Smoking is not permitted within or around the facilities. GOVERNMENT RESPONSIBILITIES: The facility will promptly inspect the blood and blood components upon receipt and report any actual or suspected damage, irregularity, testing or labeling error. The facility will also promptly report blood lost due to shipping error. The facility 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 facility will report possible transfusion-transmitted infections or other serious complications associated with transfusion which may have resulted from blood ("Adverse Event"). The facility 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. PROJECT PLAN: The Contractor shall detail their priority for handling unusual needs if each facility was in an emergent situation. The Contractor shall provide their plan for product availability if there is a disaster. How and when would they supply the facilities if products became scarce or unavailable (i.e. Who does the Contractor use as your back-up supplier?) ADDITIONAL INFORMATION: The contractor shall use reasonable efforts to supply the government with the blood as set forth in this contract, contingent upon availability of the blood, an adequate amount of voluntary blood donations, and a lack of force majeure events as set forth in 28 CFR 52.212-4(f). The government understands that 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 AABB, America's Blood Centers, the American Red Cross, and the Armed Services Blood Program 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 the negligence or misconduct of the contractor. PROPOSAL REQUIREMENTS: The Contractor shall identify and provide the pricing for the base year for any blood or service that is not included in this contract (i.e. new testing that may become available during the initial and/or option years of the contract). A projection of the estimated quantities of products and services required for the next year is listed by the Fargo VA (see Attachment A). Quantities listed in the attachment to this are estimates based upon prior history of actual volumes and are intended to provide the potential contractor a basis for calculating their pricing. They are not a guaranteed minimum. B.3 PRICE/COST SCHEDULE- Refer to attached spreadsheet for blood products and testing. ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 1.00 EA __________________ __________________ BLOOD PRODUCTS AND REFERENCE LAB TESTING FOR BLOOD BANK Contract Period: Base POP Begin: 10-01-2025 POP End: 09-30-2026 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals 1001 1.00 EA __________________ __________________ BLOOD PRODUCTS AND REFERENCE LAB TESTING FOR BLOOD BANK Contract Period: Option 1 POP Begin: 10-01-2026 POP End: 09-30-2027 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals 2001 1.00 EA __________________ __________________ BLOOD PRODUCTS AND REFERENCE LAB TESTING FOR BLOOD BANK Contract Period: Option 2 POP Begin: 10-01-2027 POP End: 09-30-2028 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals 3001 1.00 EA __________________ __________________ BLOOD PRODUCTS AND REFERENCE LAB TESTING FOR BLOOD BANK Contract Period: Option 3 POP Begin: 10-01-2028 POP End: 09-30-2029 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals 4001 1.00 EA __________________ __________________ BLOOD PRODUCTS AND REFERENCE LAB TESTING FOR BLOOD BANK Contract Period: Option 4 POP Begin: 10-01-2029 POP End: 09-30-2030 PRINCIPAL NAICS CODE: 621991 - Blood and Organ Banks PRODUCT/SERVICE CODE: 6505 - Drugs and Biologicals GRAND TOTAL __________________ 2. DELIVERY OF ITEMS The address is with FOB Destination shipping: FARGO VA Health Care System 2101 Elm Street North Fargo, ND 58102-2417 This notice of intent is not a request for competitive quotes and no solicitation will be made available. Any responses received will only be considered for the purposes of determining whether to conduct a competitive procurement in lieu of sole source contract described in this notice, and such determination shall be made at the sole discretion of the Government. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the requirement. If no responses are received, the government will proceed with the Sole Source acquisition. The Government will not pay for information submitted. All quotations/responses should be emailed to Alberta Mickells at Alberta.Mickells@va.gov by 05/13/2025 at 10:00 a.m. Central Standard Time. INSTRUCTIONS: RESPONSES MUST INCLUDE THE FOLLOWING INFORMATION: Primary Information: Company Name: Point of Contact (POC) name: Email address: Phone number: Unique Entity ID No. listed in the System of Awards Management (SAM): Please indicate your business classification for NAICS 621991 below: _____ Small Business _____Other than Small Business If your business classification is Small Business, do you qualify under any of the following certification programs and socio-economic category? _____ Service Disable Veteran Owned Small Business (SDVOSB) _____ Veteran Owned Small Business (VOSB) _____ HUBZone _____ Women Owned Small Business (WOSB) _____ 8(a) If a SD/VOSB set-aside is determined to be issued for this request, will you be able to comply with VAAR 852.219-76 for supplies? Please indicate whether you hold a GSA Federal-Supply-Schedule contract that covers this type of request. If so, please provide the Schedule contract number. If you are not the manufacture of the requested product, do you have an Authorized Distributorship Letter issued from the manufacturer (If applicable)? The Government will not pay for information submitted. All quotations/responses should be emailed to Alberta Mickells at Alberta.Mickells@va.gov by 05/13/2025 at 10:00 a.m. CST. No telephone requests will be accepted.