6505--Source Sought Notice - 629-21-1-043-0002 - Blood Products and Services

This is a sources sought/market research synopsis. The Alexandria VA Health Care System (AVAHCS), Pineville, LA contracting office is performing market research to ascertain whether there are potential sources and their business size classification: HUB-Zone, 8(a), Small Business, Small Disadvantage Business, Women Owned Business, Service Disabled Veteran Owned Business (SDVOSB), or Veteran Owned Small Business (VOSB). Preferably SDVOSB/small businesses. The NAICS Code is 621991. The Southwest Louisiana Veterans Healthcare System (SLVHCS), New Orleans, LA requires blood and blood products. The contractor shall provide the following: Statement of Work Purchase of Blood Products and Services Southeast Louisiana Veterans Health Care System New Orleans, LA 12/16/2019 1. PURPOSE 1.1 The intent of this solicitation is to provide a primary source for procurement of blood and blood products, autologous donor collection, delivery services, reference laboratory services, and therapeutic procedures for SE Louisiana Veterans Health Care System (SLVHCS), Pathology & Laboratory Medicine Service (P&LMS) Transfusion Medicine, 2400 Canal St, Room 4E122, New Orleans, LA 70119 from October 1, 2020 through September 30, 2021, with full 4 option years October 1, 2021 through September 30, 2025. This is an indefinite delivery, indefinite quantity contract with firm-fixed price task/delivery orders placed against it. 2. GENERAL INFORMATION 2.1. VA Blood requirements: 2.1.1. Non-personal Services: Contractor shall provide non-personal services to include all management, tools, supplies, equipment, labor, transportation and applicable licenses and permits necessary to provide blood to the SLVHCS Veterans in accordance with specifications and as recommended in the current editions of the Standard for Blood Banks and Transfusion services and the Technical Manual of the American Association of Blood Banks (AABB). 2.1.2. Period and Place of Performance: The Period of Performance shall be a base period plus four option years which will be exercised at the Government s discretion. Performance shall start October 1, 2020. Place of Performance shall be Contractor s facility in the State of Louisiana. Base Period = 10/1/2020- 9/30/2021 Option year 1 = 10/1/21 - 9/30/22 Option year 2 = 10/1/22 - 9/30/23 Option year 3 = 10/1/23 - 9/30/24 Option year 4 = 10/1/24 - 9/30/25 2.1.3. Contractor Personnel: The contractor shall assume full responsibility for the protection of its personnel furnishing services under this contract, such as, but not limited to, providing worker s compensations, professional liability insurance, health examinations, income tax withholding, and social security payments. The parties agree that such personnel shall not be considered VA employees for any purpose and shall be considered employees of the Contractor. Contractor staff must comply with SLVHCS Information Security requirements. 2.1.4. Safety Considerations: Contractor shall provide and utilize safety requirements during the contract period. Proposals will be considered only from offerors whose blood bank is currently registered and/or licensed with the Food and Drug Administration (FDA), Department of Health and Human Services pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, 21 USC Section 260. Additionally, the contractor shall certify that he/she will comply with the applicable FDA requirements outlined with respect to donors, containers, delivery, etc. All blood requirements shall be performed in strict compliance with subject Statement of Work. 2.1.5. Qualifications: a) Contractor must be a manufacturer of blood and blood products. Proposals will be considered only from offerors whose blood bank is currently registered and/or licensed with the Food and Drug Administration (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. b) Contractor must be capable of performing as a reference lab, 24 hours a day/365(366) day a year, to the SLVHCS Blood Bank. c) Contractor must be capable of providing therapeutic procedures on the SLVHCS station when necessary, including but not limited to Therapeutic apheresis, red cell exchange, plasma exchange, and therapeutic phlebotomy. d) Contractor s primary blood center or depot must be located within 50 miles or 1 hour of the SLVHCS location. e) Personnel assigned by the contractor to perform the services covered by this contract shall be licensed, as appropriate, in a State, Territory, or Commonwealth of the United States or the District of Columbia. 2.1.6. Medical Records: Clinical or other medical records shall be exchanged as needed by both facilities and remain confidential 2.1.7. Blood Donation: The contractor shall provide the SLVHCS only with 100% volunteer donor blood in accordance with FDA rules and regulations most current version. Definition of volunteer donor is as follows: A volunteer donor is a person who does not receive monetary payment for blood donations. 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. 2.1.8. Donor List: a) The offeror must maintain readily available blood donor lists including names, addresses and social security numbers. Such lists should indicate whether and on which date blood of a particular donor was furnished to the Department of Veterans Affairs under this contract period. b) Donor selection must be in accordance with criteria established by the FDA and/or the AABB. c) The Contractor shall ensure that all donor and blood component records are identifiable and traceable. 3. SPECIFICATIONS 3.1 Requirements for Blood Products and General Services 3.1.1 Blood will be typed and labeled for ABO and Rh antigens and screened for unexpected antibodies in accordance with methods recommended in the current edition of Standards for Blood Banks and Transfusion Services and the Technical Manual of the American Association of Blood Banks. All blood shall be tested as required by the Food and Drug Administration (FDA), the American Association of Blood Banks (AABB), all applicable state regulatory agencies, laws, rules, and regulations and the Code of Federal Regulations, 21 CFR Parts 606,607,610,630,640,660, governing blood products. Products must be non-reactive for infectious disease markers prior to shipment, except with the express written authorization of the SLVHCS Blood Bank Medical Director or his/her designee. The Contractor and SLVHCS shall maintain standards in accordance with FDA, AABB, all applicable state regulatory agencies, laws, rules, and regulations, including OSHA Blood Borne Pathogen Exposure Final Rule 29 CFR Part 1910.1030, effective November 12, 2015, and any subsequent revisions thereof. a) All blood shall be collected by the closed system under aseptic conditions and shall be stored in currently approved, appropriate solutions and the container shall be correctly labeled. The label shall also bear the expiration date of the contents which shall not exceed the FDA approved time for the specific anticoagulant. b) Autologous and Directed blood/blood components will be typed for ABO and Rh (D), and unexpected antibodies in accordance with licensed methodologies, and will be tested for all transfusion transmitted disease markers currently required by the FDA or AABB, whichever has the most stringent requirements. This testing will be updated as requirements are identified by FDA or AABB. Descriptions of testing are required for each testing site. c) All blood supplied will be grossly free of hemolysis, excessive chyle, and clots. d) The Contractor shall provide blood and blood products as available when ordered and SLVHCS shall purchase blood and blood products according to the appropriate fee schedule. e) The Contractor shall provide the appropriate fee schedule with their proposal. 3.2 Blood and Blood Product Requests and Delivery 3.2.1 Routine Blood and Blood Product Requests a) The blood supplier must be available to accept and deliver orders 24 hours a day, 7 days a week including all Holidays. b) Routine orders placed by 8 am daily will be delivered no later than 12 pm the same day. Additional routine orders will be accepted as needed throughout the day and delivered within 4 hours. c) These standards will be met for all blood types. When, due to system wide supply and/or demand, the above delivery times cannot be met, the contractor will provide the SLVHCS with an estimated time of delivery and regular updates if the estimate is not met. d) The above standard does not include rare units, those where antigen matching is required, which will be delivered as soon as possible. The contractor will provide the SLVHCS Blood Bank an estimated time of delivery with updates on delivery progress as needed. 3.2.2 Emergency (STAT) Blood and Blood Product Requests a) Emergency (STAT) requests for blood and blood products must be processed immediately and made available within one (1) hour of the notification of need. b) In the event the contractor is unable to meet the demand for product, contractor shall notify the SLVHCS within 10 minutes of product request. 3.2.3 Delivery of Blood and Blood Products a) The Contractor shall pay delivery expenses of blood and blood products to and from the SLVHCS using the agreed upon method of delivery . b) All blood and blood product deliveries under this contract will be delivered to The SE Louisiana Veterans Health Care System, 2400 Canal Street, D&T Bldg. Room 4E122C, New Orleans, LA 70119. c) All Shipping invoices or documents will be provided with all deliveries of products. d) Client will be responsible for receipt inspection and for reporting to the Contractor any damaged or non-conforming blood product issues within twenty-four (24) hours of delivery. 3.3 Storage and Packaging a) Immediately after bleeding, the blood shall be refrigerated between 1 and 6 degrees Celsius with fluctuation of no more than 1 degree Celsius within this range. Freezing must be avoided at all times. b) When platelets will be separated from donor blood, the blood may be stored at room temperature up to eight hours. c) All blood delivered under this contract shall be properly packaged and insulated in such a way to insure that a proper temperature appropriate for the product is maintained during transport between the contractor s place of business and the SLVHCS location. The Contractor shall meet all federal and state DOT requirements for the transportation of human blood and blood products. 3.4 Return Policy a) The Contractor must provide routine exchange, 7 days per week, of a platelet apheresis to the SLVHCS to ensure availability of at least one platelet apheresis product at all times for our patients at no additional costs. SLVHCS will be charged only for products transfused, with no hidden fees. b) The Contractor shall accept unused red cell units for full credit provided the following requirements are met by the hospital: i) the red cell units must have at least seven (7) days of shelf life remaining, ii) the red cell units must have at least five (5 ) segments, iii) the red cell units must have been stored and handled by the SLVHCS in accordance with the requirements of the American Association of Blood Banks (AABB), and the Food and Drug Administration (FDA). b) SLVHCS will be credited irradiation fees when an irradiated product is delivered due to limited inventory. c) Full credit will be given for damaged products such as fresh frozen plasma with broken bags or RBCs with clots. d) There will be no credit or return for autologous or directed donations 3.5 Reference Laboratory Testing a) The Contractor shall provide AABB accredited reference laboratory services for difficult antibody identifications, antigen screening, elution, absorption, RBC treatment, patient phenotyping, and other special unit screening (CMV and Sickle) to the SLVHCS twenty-four (24) hours per day, seven (7) days a week. b) Specimens for reference laboratory testing will be picked up at the SLVHCS and delivered to the reference laboratory for testing within two hours of request. The contract reference laboratory will be responsible for the specimen pickups once notified by the SLVHCS. c) Appropriate testing and location of antigen negative units will be completed as soon as possible, not to exceed 72 hours for complex cases. d) Problem workups shall be reported by telephone and faxed to the SLVHCS Pathology Blood Bank laboratory immediately upon completion and followed with a written report within 48 hours. e) The Contractor will maintain an inventory of frozen rare donor cells and have access to the AABB rare donor file. 3.6 Therapeutic Procedures, Autologous and Directed Procedures, Irradiation of Products a) Contractor must be able to provide qualified services/resources for therapeutic procedures on the SLVHCS Station when necessary. Therapeutic procedures shall be available on an as needed basis with routine scheduled and emergency procedures available. A good faith effort will be made to meet the needs of the patient in a timely manner. b) Contractor shall provide all labor, equipment, technique, qualified personnel, and expertise necessary to provide therapeutic procedures to include but not limited to therapeutic apheresis, red cell or plasma exchange services, and therapeutic phlebotomy at SLVHCS as needed under the direction and control of the vendor s Chief Pathologist or Medical Director of the vendor s Blood Bank. c) All contract personnel shall complete the SLVHCS VetPro credentialing process as required by VA policy prior to performing all therapeutic procedures on site. See required form attachment VetPro Enrollment Form. The contractor verifies that all contract personnel shall be responsible for compliance with all American Association of Blood Banks (AABB) standards relating to therapeutic procedures. All contract personnel are trained and competency assessed by the vendor and records shall be retained by the contractor and available to SLVHCS upon request. The contractor is responsible for maintaining current contractor staff credentialing with SLVHCS (notification of staff changes must be submitted immediately). Non credentialed staff will not be allowed to perform contracted procedures. d) Contractor is responsible for ensuring that contract personnel are not using illegal drugs and are subject to random drug testing performed by the contractor. Contractor shall be responsible for ensuring that all contract personnel have received a Hepatitis B vaccine or signed a voluntary declination or have documented proof of immunity to Hepatitis B infection. e) Contract personnel must comply with SLVHCS procedures for gaining access to the facility. SLVHCS reserves the right to refuse acceptance of contract personnel whose personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Standards of conduct shall mirror those prescribed by current Federal personnel regulations. f) All equipment records (for any instrument that may be used at SLVHCS) should be provided by the contractor to SLVHCS contract COR, Blood Bank Technical Specialist, and Clinical Engineering. These should be provided as hard copies, in binders, to the COR and Blood Bank Technical Specialist and as electronic copies to Clinical Engineering via contact@example.gov. Records should include initial inspection and all preventive maintenance documentation. All maintenance and/or repair records should be provided immediately upon servicing of equipment. Prior to any use on SLVHCS patients, SLVHCS Clinical Engineering Staff must perform a safety check. g) The SLVHCS transfusion service will receive copies of all required documentation for therapeutic procedures. h) The replacement fluids will be provided by the SLVHCS transfusion service. i) The contractor shall designate a contact person who shall be responsible for coordinating therapeutic services for SLVHCS requests. j) The Contractor must be able to collect and process all autologous, directed and allogeneic blood requests. k) Contractor shall provide component irradiation services in a manner that irradiated cellular products are available to the SLVHCS as needed. Irradiated products must be available upon request within 2 hours after time of request. 3.7 Processing Fees and Invoicing (monthly invoicing for products and services) a) Payment will be made by the SLVHCS upon receipt of properly prepared invoice submitted to the Austin Financial Center through OB-10 or current payment submission specifications. b) Payment will be monthly in arrears. c) To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this contract. Further the Contractor is required to certify in its proposal that all persons listed in the contractor s proposal have been compared against the OIG list and are NOT listed. During the performance of this contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. 3.8 Adverse Event Reporting a) VA will notify the Contractor of any possible infectious disease or other serious complication associated with transfusion that may have resulted from any of the blood, including suspected post-transfusion hepatitis, transfusion-associated HIV or HTLV infection, and any other transfusion-associated infections (malaria, babesiosis, bacterial contamination or infection) and death. Recalled and Defective Products The contractor will promptly notify the SLVHCS for all transfusion transmitted disease markers currently required by the FDA or AABB including by not limited to potentially HIV-infectious blood or blood products. In the event of a recall, copies of the recall request must be sent promptly to the Medical Director and/or the Blood Bank Supervisor at the SLVHCS. 3.10 See attachments for Product Estimate and Services Estimate for items required by SLVHCS, and estimated quantities 4. Security: In accordance with Handbook 6500.6 Contract Security (March 12, 2010) include this contract security language into the Statement of Work (SOW) immediately following the security clause section: "A&A requirements do not apply--Security Accreditation Package is not required". 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. This notice is to assist the VA in determining sources only. This is not a solicitation for proposals or quotes. A solicitation will be issued at a later date and time. All information submitted in response to this sources sought notice is considered voluntary. Interested and capable respondents are requested to provide: company name, address, point of contact, phone number, DUNS number, geographical location, business size and number of employees. Responses to this notice shall be e-mailed to Lonest Bonton, Contracting Officer at e-mail address: contact@example.gov. Telephone responses will not be accepted. Reponses must be received by no later than COB (4:30pm CST), June 30, 2020.