Q301--Roseburg and Eugene Blood and Blood Products

Sources Sought The VA Roseburg Health Care System is issuing this sources sought as a means to conducting market research to identify parties having an interest in and the resources to support a requirement for blood and blood products for a base period and 4 option years. The purpose of this Sources Sought Announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified sources. This is not a request for quotations. The Department of Veterans Affairs, NCO20 is looking for sources of the following: STATEMENT OF WORK (SOW) Contractor shall provide healthcare resources as stated herein and in accordance with Public Law 104.262 and 38 U.S.C. 8153. Contractor agrees to provide the following blood and blood components in support of the Boise VA Medical Center in Boise Idaho. 1. Blood shall be typed for ABO and Rh antigens in accordance with methods recommended in the current edition of Standards for Blood Banks and Transfusion Services and Technical Manual of the American Association of Blood Banks. All blood shall be collected by the closed system under aseptic conditions and shall be processed in appropriate solutions and the container so labeled. The label shall also bear the expiration date of the contents, which shall not exceed 42 days from date of collection of source blood. (This only applies to red blood cells collected and stored in AS; it does not apply to platelets, frozen plasma, or Cryo). All blood supplied will be grossly free of hemolysis, excessive chyle and clots. 2. Contractor shall be currently registered and 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 and certified by the American Association of Blood Banks. 3. Contractor shall submit proof that they hold 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. 4. All products, if interstate shipment of blood or blood component is involved, must submit a statement that such approval has been authorized under section 251 of the Public Health Service Act, as amended, 42 USC Section 262. All products delivered shall be FDA licensed. 5. The contractor certifies that they shall comply with the requirements outlined below with respect to donors, containers, delivery, etc. 6. The Contractor shall only provide the VA with 100% "volunteer donor" blood in accordance with FDA rules and regulations effective May 15, 1978 or later revision. 7. Contractor shall submit copies of their annual license and certifications each year, or upon request from the government. 8. Contractor shall submit proof of AABB accreditation and CLIA certification upon request of the government. 9. Donor Requirements: a) Donor selection must be in accordance with criteria established by the FDA and the AABB. 10.Blood Products: a) Whole blood, red blood cells and components shall be supplied in standard FDA licensed collection containers. b) Contractor, prior to delivery, shall complete the following tests: ABO Grouping RHo(D) Testing Serology (S.T.S.) Irregular Red Blood Cell Antibody Detection Hepatitis B Surface Antigen (KHB-sAg) HIV I/II Antibody Screening Hepatitis C Virus (HCV) Antibody, and Antigen. Hepatitis B Core Antibody (HbcAb) Screening HTLV 1/1I Antibody Screening HIV-1Antigen Aantibodies to Chagas Disease (Trypanosoma cruzi) West Nile Virus Other tests as may be included for licensure by the Office of Biologics/Food and Drug Administration c) The above work shall be completed on all blood and its components prior to shipment. In emergent situations, some blood may be sent before testing is complete. In the event of an emergent situation, an emergency release form shall be signed by both the contractor and the VA. 11. All blood and blood components shall be prepared, stored and transported in compliance with the current American Association of Blood Bank standards, and Federal Drug Administration regulations, including appropriate labeling for directed and autologous donations and irradiated products. Emergency requirements shall be delivered within two (2) hours and the contractor shall be responsible for the cost of delivery. Both parties agree in the event there is an issue with antibodies and/or compatibility of the blood type requested, or if the product requires washing, volume reduction, additive removal, splitting or other manufacturing processes, the delivery time may be longer than 2 hours. The Contractor shall notify VA immediately in the event the requirement will not be delivered within 2 hours. It is the responsibility of the contractor to arrange for pickup of specimens and delivery of blood products in an emergency. Routine Blood Products will be delivered the next day. Longer outdates will be delivered when possible. All blood delivery to, or picked up by, the VA Medical Center under this contract shall be properly packed and insulated in such a way as to insure a temperature of 1-10 degrees Celsius during a normal automobile trip between contractor's place of business and the VA Medical Center. All ordering on an as needed basis and be compatibility tested as necessary prior to delivery. Autologous blood shall be fully tested before being sent out by contractor. INVOICES: The Contractor shall invoice the VA Medical Center Monthly in arrears through the Tungsten Network. Review the information at http://www.tungsten-network.com/us/en/ for invoicing procedures. Quality Control Monitor: Contractor is required to implement and report on quality control monitors, which will review and monitor the quality and timeliness of the services provided under this contract as agreed upon by both parties. The contractor shall submit a report quarterly to the Contracting Officer s Point of Contact (POC) for review regarding the control monitors. These reports are due: April 1 (for Jan/Feb/Mar), July 1 (Apr/May/Jun), October 1 (Jul/Aug/Sep), and January 1 (Oct/Nov/Dec). The Contractor's records pertaining to potency, safety, compatibility testing and quality of units transfused to VAMC patient's will be available to the VA Medical Center upon request, with the exception of the identity of the donor. The Contractor, throughout the life of this contract, shall meet or exceed the standards of FDA and AABB concerning the recall of blood products and shall participate in look back procedures initiated by the VA Medical Center, so as not to impede the ability of the Medical Center to identify if a patient has contracted a transfusion associated disease as a result of a transfusion. If at any time the contractor fails to maintain FDA licensure and/or AABB or CAP accreditation, the government reserves the right to terminate this contract for cause. The Contractor shall perform pre-transfusion testing for the VA Medical Center, antibody identification, adverse effects of transfusion investigations, and immunity problem investigations. The Contractor shall provide 24-hour service for patient samples submitted for problem workups; shall report their resolution of the problem by telephone and/ or fax immediately and follow it with a written report within 48 hours. The Contractor shall be able to provide the following upon written (faxed or online) request: Antigen-screened leukoreduced Red Blood Cells, Cross-matched leukoreduced Red Blood Cells, and special order HLA-matched or crossmatched Apheresis Platelets. The Contractor shall modify products as requested and as necessary for the protection of the patient, to include, but not limited to leukocyte reduction and irradiation. The Contractor shall maintain a quantity and/or type specific or type compatible products to include but not limited to the following products in-order to meet the needs of the VA Medical Center: Red Blood Cells all 8 groups Fresh Frozen Plasma (FFP) to include, but not limited to group AB Cryoprecipitate to include, but not limited to group AB Apheresis platelets all 4 ABU groups Large Volume Delayed Sample (LVDS), Irradiated- As needed/requested Pathogen Reduction Technology (PRT)- As needed/requested Credits accrued and used each month will be forwarded on a monthly statement to the POC If the Contractor fails to meet FDA requirements, the Contractor shall continue to supply the VA Medical Center and perform compatibility testing and other testing as stated herein as the agreed upon pricing. No additional charges shall be imposed on the VA if the Contractor must import products. If the Contractor is unable to recruit enough donors to meet the community needs and the needs of this Medical Center, it shall be the Contractor's responsibility to import blood products in order to meet the Medical Center's requirements at no additional costs. The VA Medical Center will not be required to provide confidential patient information unrelated to patient care unless it relates to the transfusion. All confidential patient information must be requested through the "Release of Information" office. The VA Roseburg Health Care System recognizes there are a limited amount of resources of blood components in the region and will attempt to reduce outdating. The oldest blood components are to be used first when clinically feasible. VA will, upon request, provide vendor an inventory of blood on hand. VA agrees to conform to FDA and CAP requirements regarding reporting, handling, storage and shipping of blood components. VA is CAP accredited. Contractor shall perform blood storage audits as necessary. VA agrees to appoint a committee, which has the following responsibilities: Review the transfusion of blood, blood components and derivatives in the Medical Center as required by the Joint Commission of Accreditation of Hospitals. Make recommendations to the medical staff concerning the proper usage of blood products. Insure that adequate records of transfusions and transfusion associated reactions are kept. 32. The VA understands that no credit will be given for the following, unless transfer or return is preauthorized or requested by vendor. Deglycerolized Red Cells Washed Red Cells Autologous Blood Products Additive removed Red Cells Leukocytes Fresh Frozen plasma/cryoprecipitate maybe returned for credit if they have remained frozen, stored and transported appropriately and returned to vendor at least 30-days before the expiration date. Special processing fees such as for irradiation of blood products. 33. GOVERNING LAW: This contract shall be governed, construed and enforced in accordance with Federal Law. 34. MARKETING: Contractor shall not advertise or use any marketing material, logos, trade names, service marks, or other material belonging to the VA without the VA's consent. 35. ORDER OF PRECEDENCE: The terms, conditions, and attachments referenced herein, including any formal written modifications thereto, constitute the complete agreement between the parties and take precedence over any other language, oral or written. 36. ORDER PLACEMENT: Task orders will be issued by the Network Contracting Office 20 to fulfill requirements on an as needed basis. Unit quantities are currently unknown. Each individual task/delivery order will state the unit quantities of supplies and/or services required at time of issuance. Orders will be placed orally, facsimile, or by email All orders placed under this IDIQ must contain the following information: Date of order Contract number and order number Contract item number and description, quantity, and unit price Delivery or performance schedule Place of delivery or performance Any packaging, packing, and shipping instructions Accounting and appropriation data. Method of payment and payment office 37. GOVERNMENT S MINIMUM & MAXIMUM QUANTITY: The VA attempts to be as accurate as possible when providing estimated quantities; however, actual dollar value quantities may vary from the dollar value quantities as listed in the price schedule. The Government s guaranteed minimum amount to be ordered for the length of this contract is $1,000.00. The government s maximum amount to be ordered during the length of this contract is $1,836,361.80. 38. SECURITY REQUIREMENTS: The contractor employees shall not have access to VA sensitive or computer information and will not require routine access to VA Facilities. The contractor employees shall have intermittent access only and will be escorted by VA employees while at VA Facilities. No background investigation is required 39. FEE SCHEDULE & INVOICING: Task and delivery orders will be issued to order various supplies and services stated in the attached fee schedule. The contractor may give discounts from the stated prices; however, the contractor shall never quote or invoice for more than the stated prices in the given fiscal year. CREDIT FOR RETURNED BLOOD AND COMPONENTS: Credit prices are the same prices as charged in the contract. Full credit shall be given when blood products are sent to the VA with less than 10 days dating and outdate at the VA. Full credit will be given if all seals on the unit have not been entered and are intact. Full credit will be given if the unit label is clean, unmarred and all labels applied by the VA have been removed. In order to receive full credit, a completed and signed Product Return/Transfer Form must accompany all units returned to Contractor. The VA staff member's signature indicates that the unit(s) was properly stored, not entered, and the unit label is intact. When units for which special testing has been completed are returned for credit, credit will be given for the unit only. Irradiated units required by the VA are not returnable and no credit will be given for the irradiation process. ALLOGENEIC RED BLOOD CELLS (All conditions listed must be meet in order to receive credit) Full credit shall be given if returned unit(s) have at least 21+ -days remaining to expiration (outdate). If red cells are delivered to VA with fewer than 10 days shelf life, the VA may return for full credit. Full credit shall be given if the unit has been continuously stored within 1 to 6 degrees Centigrade in a refrigerator that is monitored by an alarm system and recording chart. Contractor may request copies of the temperature records (charts) to document proper temperature storage on units of blood returned to the Center. Full credit shall be given if all seals on the unit have not been entered and are intact. Full credit shall be given if the unit label is clean, unmarred and all labels applied by the VA have been removed. In order to receive full credit, a completed and signed Product Return/Transfer Form must accompany all units returned to Contractor. The VA staff member's signature indicates that the unit(s) was properly stored, not entered, and the unit label is intact. When units for which special testing has been completed are returned for credit, credit will be given for the unit only. Irradiated units required by the VA are not returnable and no credit will be given for the irradiation process. AUTOLOGOUS AND DIRECTED UNITS Autologous units are not formally returned to the Contractor and no credit will be given. These units should be destroyed by the VA if not used. Directed units can be returned for credit if unit has at least 21+ days remaining to expiration (outdate). The credit shall be for the unit cost, excluding the special handling fees PLATELETS AND PLATELEPHERESIS Vendor will assist to transfer un-needed platelets to another facility as need arises and as possible. Platelets transferred to another facility will receive full credit for the VA. Random donor platelets are not used in the Roseburg area. Autologous platelets and autologous platelepheresis are not returnable and no credit will be given. Directed platelepheresis is not returnable and no credit will be given. All allogeneic platelets (random) and apheresis platelets will be given full credit if received on day of outdate (short-dated) if they outdate at the VA. Credit per sections A and D are contingent upon the following: Full credit will be given if the unit has been continuously stored within 20 24 degrees Centigrade on a platelet rotator that is monitored by an alarm system and recording chart. Contractor may request copies of the temperature records (charts) to document proper temperature storage on units of platelets returned to the Center. FRESH FROZEN PLASMA, CRYOPRECIPITATE AND DERIVATIVES These products are not returnable from VA. Cryo and FFP, which have a minimum of 90-days, left until expiration, Contractor will assist with transfer to another Hospital as needed to utilize products. Autologous fresh frozen plasma is not returnable, and no credit will be issued. Directed fresh frozen plasma is not returnable and no credit will be issued. All allogeneic FFP, Cryo, and derivatives will not be given full credit, but Contractor will assist with transfer out to another hospital as needed to utilize products. PAYMENT: Credits for returned blood will be reflected on the next or current invoice. In the event that a cash payment for returned blood is deemed necessary, remit payments to: VA Roseburg HCS 913 NW Garden Valley Blvd. ATTN: FISCAL SERVICE Roseburg, OR 97470 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. 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 4 hours. AUTOLOGOUS: Blood drawn from a donor-patient for subsequent transfusion; in this case, restricted to pre-deposit units of blood, i.e., not including intra-operative or post-operative blood salvage. BLOOD GROUP: ABO Blood group plus the Rho(D) type of the unit, specifically 0+, 0-, A+, A-, B+, B-, 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 are 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. CRYOPRECIPITATE: 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. 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. PLATELETPHERESIS: 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 (RANDOM): Platelet component that is prepared from a single unit 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. 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: Typings 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 in order to improve recruitment and minimize waste. 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. 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. Potential sources shall provide, at a minimum, the following information to Point of Contact listed below: 1) Company name, address, and point of contact, phone number, e-mail address, and DUNS. 2) Please identify your company s size in comparison to the anticipated North American Industry Classification System (NAICS) code 325413 In-Vitro Diagnostic Substance Manufacturing. To be considered a small business your company must have fewer than 1,250 employees. 3) Any Service Disabled Veteran Owned Small Businesses or Veteran Owned Small Businesses who responds to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. 4) The Non-Manufacturer Rule (NMR) will apply if there is a decision to set-aside the procurement. 5) Potential sources shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. This procurement is for new products ONLY; no remanufactured or "gray market" items. All products must be covered by the manufacturer's warranty. Responses are due by 11/27/2020 10:00 AM PST, to the Point of Contact. The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this source sought notice. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Notice to Potential Offerors: All Offerors who provide goods or services to the United States Federal Government must be registered in the System Award Management (SAM located on the web at www.sam.gov). It is desirable that any Offeror to have completed their business Online Representations and Certifications Application in the System for Award Management (SAM). Point of Contact: Ty Draszt | Contract Specialist contact@example.gov | +1 (555) 000-0000