Blood & Blood Products Veterans Health Affairs, Network Contracting Office 5, is issuing this Notice of Intent to Sole Source in order to identify any potential sources that have the resources and capabilities to provide Blood & Blood Products at the Washington, DC VA Medical Center, 50 Irving St. NW, Washington DC 20422. The government is contemplating an Indefinite Delivery, Indefinite Quantity Firm Fixed Price contract to satisfy this requirement and meet the needs of the Washington, DC VA Medical Center. SCOPE Please see the list below. PLACE OF PERFORMANCE Washington, DC VA Medical Center Pathology & Laboratory Medicine Blood Bank (GA-102) 50 Irving St. NW Washington DC 20422 TRAVEL N/A CLASSIFICATION/SECURITY N/A GOVERNMENT FURNISHED PROPERTY None. INTERESTED & CAPABLE RESPONSES NCO 5 is seeking responses from businesses that are interested in this procurement and consider themselves to have the resources, rights, and capabilities necessary to provide these services. Please respond with your: Business name Business type Socio-economic status (e.g., Veteran-Owned, Woman-Owned, Disadvantaged Small Business, 8(a), etc.) Person of contact (including telephone number & email address) GSA Contract number if applicable DUNS number and SAM UEI number Capability statement Responses must be submitted by 1:00 PM (EDT) Monday, July 18, 2022. Responses to the information requested above may be submitted via email to
[email protected]. No telephone calls will be accepted. DISCLAIMERS This Notice of Intent to Sole Source does not constitute a solicitation. All information received in response to this notice that is marked proprietary will be handled accordingly in accordance with (IAW) Federal Acquisition Regulation (FAR) 15.201(e). Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses incurred associated with responding to this RFI. This Special Notice of Intent to Sole Source is for planning purposes ONLY. The results of this notice will assist in the development of (1) the requirement, and (2) the acquisition strategy (e.g., small business set-aside, full and open competition, etc.). VA assumes no responsibility for any costs incurred associated with the preparation of responses submitted as a result of this notice. STATEMENT OF WORK B.2 SCHEDULE OF SUPPLIES/SERVICE AND PRICE OR COST The Contractor shall provide the following blood, blood components and reference blood testing services to the Department of Veterans Affair Medical Center, Washington, DC in accordance with the requirements and estimated quantities noted below. The quantities shown are estimates only. (A) BLOOD AND BLOOD COMPONENTS: CLIN CORE PRODUCTS DESCRIPTION UNIT OF ISSUE EST. QTY 0001 Red Blood Cells Leuko-reduced (Human) Random Type UNIT 2000 0002 Platelet Pheresis, Leukodepleted UNIT 200 0003 Cryoprecipitate AHF (single units) UNIT 10 0004 Cryoprecipitate, Pooled (5u/pool) UNIT 100 0005 FP24 UNIT 500 Delivery Terms and Fees: Up to 3 routine deliveries per week, Monday-Friday at no charge Ad hoc Delivery Fees may apply (B) REFERENCE LABORATORY TESTING SERVICES: The contractor will provide Reference Consultation, HLA typing, platelet antibody screen and other Immunohematology blood testing on an as needed basis. B.3 SPECIFICATIONS/STATEMENT OF WORK In addition to the blood and blood products listed in section A., the contractor will also provide Reference Consultation, HLA typing, platelet antibody screen and other blood components such as granulocytes on an as needed basis. Blood will be typed for ABO/Rh antigens in accordance with methods recommended in the current edition of Standards for Blood Banks and Transfusion Services and AABB Technical Manual. Blood from each donation will be tested for syphilis and only those tested non-reactive will be used for transfusion. In addition, blood tested negative for the following antibodies namely, human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg) and anti-hepatitis B core antigen (anti-HBc) will be used for transfusion. Blood and components will not be used for transfusion if the results are outside established limits. All blood is to be collected by closed system under aseptic conditions and shall be processed in appropriate solutions with the container so labeled. The label shall bear the expiration date not to exceed 21 days from the date of collection of source blood when collected and stored with anti-coagulant CPD/CP2D or 35 days from date of collection of source blood when collected and stored with anti-coagulant citrate phosphate, dextrose adenine solution (CPDA-1). AS-1/AS-3/AS-5 Red Cross (additive anti-coagulant solutions) has 42 days from date of collection. All blood components will be collected from volunteer donors and will be processed according to FDA (Food and Drug Administration) regulations and AABB (Association for the Advancement of Blood and Biotherapies) standards. The contractor shall supply the VA with assurance of the following: Traceability of all products from collection to delivery Quality management systems are in place. Current Good Manufacturing Practices are followed. The contractor shall have the following licenses and or registrations and shall make them available for review by the VA with the proposal: The Contractor shall maintain an unrevoked U.S. 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. If the Contractor is involved in interstate shipment of blood or blood component is involved, the Contractor must maintain approval authorized under Section 251 of the Public Health Service Act, as amended, 42 USC Section 262. The Contractor s blood bank must maintain registration and/or licensing 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 always during the contract period. Certificate of Accreditation under the CLIA (Clinical Laboratory Improvement Act) of 1988 or current certification by the CAP (College of American Pathologists). The Contractor shall deliver the components under storage conditions as required by FDA and AABB regulations and standards. Red Blood Cells delivered shall have a dating period of fourteen (14) days or more from the date of delivery. Blood components will be labeled as to the A, B, O and Rh type. Immediately after bleeding, the blood shall be refrigerated between 1 and 6 C with fluctuation of no more than 2 C within this range. Freezing must be always avoided. If public transportation of the blood is necessary, it shall be transported in clean shipping containers provided with refrigeration sufficient to hold the blood at 1-10 C if it has been re-cooled. If the blood has not been cooled, the shipping containers shall provide sufficient refrigeration to bring the temperature toward 1-10 C, preferably 1-6 C while in transit. CONTRACTOR REQUIREMENTS The Contractor shall furnish all personnel, supplies and facilities necessary to collect, process, store and deliver human blood components and derivatives. The blood bank must currently be 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. The Contractor must submit proof that he holds an unrevoked U.S. License which is issued by the Director of Biologics, Food and Drug Administration (FDA) under Section 351 of the Public Health Service Act, as amended, 42 USC Section 262, as a source of supply for whole blood. Specimen and blood components must be transported and shipped in such a way as to ensure the integrity of specimens and blood components and comply with accreditation standards and requirements as defined by the FDA and AABB. If interstate shipment of blood or blood component is involved, the Contractor must submit with the offer a statement that such approval has been authorized under Public Health Service Act 351, as amended 42 USC Section 62. Contractor shall provide human blood components only from volunteer donors in accordance with the latest FDA regulations. A volunteer donor is a person who does not receive monetary payment for blood donations. Contractor shall protect and Veterans personal and medical information provided by the VAMC to the contractor to provide blood products or IRL services. Certification and Accreditation requirements do not apply, and a Security Accreditation Package is not required. DELIVERIES OR PERFORMANCE All deliveries shall be FOB destination within the VA s premises. Contractor agrees to deliver supplies and/or services as requested by the VA on 24-hour, 7-day week availability regardless of Federal Holidays. Deliveries designated as routine shall not carry any additional charges. Additional charges may be applied for after-hour services. Routine orders for inventory replenishment of blood products will be delivered by courier to the VA Medical Center the following morning after request. Requests for urgent or emergency delivery are made by placing an order on the ARC website (arc.bloodhub.com) or by calling the main ARC Baltimore phone number (800-233-4640). ARC personnel must be available to receive emergency and/or non-routine orders for blood and blood products 24 hours per day, seven days per week. Transportation costs for non-routine and emergency delivery will be made at the expense of the ARC, up to a maximum of twenty (20) deliveries per fiscal year. Deliveries shall be made to Veterans Affairs Medical Center, 50 Irving St., NW, , Washington, DC 20422. Attention: Blood Bank (GA 102) Items requiring lab services shall be picked up by the courier delivering blood to the VA Medical Center unless otherwise arranged with the ARC Reference Laboratory. After hours charges may be charged when the VA requests services before 8:00 AM or after 4:30 PM on any working day or any time of non-working days. Working days are Monday through Friday excluding official Federal Holidays. The eleven (11) holidays observed by the Federal Government are New Year, Martin Luther King s Birthday, President s Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving and Christmas. When a holiday falls on a Sunday, the following Monday will be observed as a legal holiday. When a holiday falls on a Saturday, preceding Friday is observed by the U.S. Government. PERIOD OF PERFORMANCE: May 1, 2023 April 30, 2028 DAYS AND HOURS OF OPERATION: Monday - Sunday, 24 hours a day including federal holidays.