The VHA Minneapolis and St. Cloud Health Care Systems require blood and blood products in accordance with the draft Statement of Work below. This is a sources sought looking for businesses to provide the supplies listed below for market research purposes. No awards of a contract will be made from this announcement. If you are a vendor that can provide the requested information above and required supplies described below with competitive pricing, send your information (to include your organization's Unique Entity Identifier number) with a description of proof of capability to:
[email protected] on or before May 22nd, 2024. Additionally, please provide answers as appropriate to the following questions in the table below with your response to this sources sought. Failure to respond to the following questions may affect the acquisition strategy. 1. Identify your organization's socio-economic category. 2. Identify if your organization is the manufacturer of the requested supplies. If you are not the manufacturer, identify the manufacturer of the supplies that you will provide and their socio-economic category. 3. Fill out the certificate under FAR Provision 52.225-2(b), identifying the item and its country of origin. ( https://www.acquisition.gov/far/part-52#FAR_52_225_2__d3401e52). If the product is a US domestic end product, write in USA for the item's country of origin. 4. State whether any of the requested services may be ordered against a government contract awarded to your organization (e.g Federal Supply Schedule (FSS), General Services Administration (GSA), etc.). 5. Address whether your organization meets the requirements of 13 CFR 121.406 (b)(1)(i), (b)(1)(ii) and (b)(1)(iii) (https://www.ecfr.gov/current/title-13/chapter-I/part-121/subpart-A/subject-group-ECFR0fca5207262de47/section-121.406#p-121.406(b)). 6. Provide estimated shipping and delivery information for the requested supplies (e.g. Expected lead time on delivery).  *If applicable, VAAR 852.219-76 VA Notice of Limitations on Subcontracting Certificate of Compliance for Supplies and Products, will apply to the potential solicitation if set-aside for Veteran Owned Small-Businesses.*  *If applicable, VAAR 852.212-71 Gray Market Items, will apply to the potential solicitation.* *If applicable, FAR Provision 52.219-14 Limitations on Subcontracting, will apply to the potential solicitation if set-aside for Small-Businesses. * Statement of Work Blood Product Supply and Transfusion Related Referral Lab Testing General Requirements: Contractor will provide the Minneapolis VA Healthcare System, 1 Veterans Drive, Minneapolis, Minnesota, 55417, herein after referred to as MVAHCS, and the St. Cloud VA Healthcare System, 4801 Veterans Dr, St. Cloud, MN 56303, herein after referred to as SCVAHCS, with blood products and transfusion related referral lab testing as specified in the schedule of items. The MVAHCS and SCVAHCS will award a 5-year firm, fixed-price, indefinite delivery indefinite quantity contract for all items listed in the Schedule of Items. Contract use will be limited to the MVAHCS and SCVAHCS. The Periods of Performance will be: Ordering Period 1: 10/1/24-9/30/25 Ordering Period 2: 10/1/25-9/30/26 Ordering Period 3: 10/1/26-9/30/27 Ordering Period 4: 10/1/27-9/30/28 Ordering Period 5: 10/1/28-9/30/29 1.A. Schedule of items: Products and services required by MVAHCS and SCVAHCS from contractor. The quantities as listed in this Schedule of Items are estimated yearly requirements. The MVAHCS and SCVAHCS attempt to be as accurate as possible when providing estimated quantities, however, actual quantities required may vary from quantities as listed below. All products and services will be requested on an on demand, as needed basis. The MVAHCS and SCVAHCS may require an unexpected blood product or reference laboratory test that is not listed in the Schedule of Items but available from the contractor. In this event, MVAHCS and SCVAHCS will pay for it at the open market list price and apply it towards the Misc. Emergency Blood Products or Testing Services category. MVAHCS and SCVAHCS will track usage and submit requests to VA contracting to update the Schedule of Items via a contract modification, if necessary. These items will be considered part of the overall contract value and together with the other tests cannot exceed the total estimated contract value. If additional fees are anticipated, contractor must submit pricing with their response to the solicitation. Schedule of Items: Item # Description Product or Test Code MPLS annual QTY St. Cloud annual QTY Total Annual QTY 1 Red Blood Cells, Leukocyte Reduced E0686V00, E0685V00, E0336V00, E0181V00, E0678V00, E0661V00 1700 200 1900 2 Red Blood Cells, Leukocyte Reduced, Irradiated E0332V00, E0668V00, E0669V00 150 60 210 3 Red Blood Cells, Saline Washed E5170V00 2 2 4 4 Platelets, Psoralen Treated E8340V00, E8341V00, E8342V00, E8343V00,E8344V00 550 80 630 5 Platelets, LVDS (Large Volume Delayed Sampling) EA007V00, EA008V00, EA009V00, EA010V00 5 5 10 6 Platelets, LVDS (Large Volume Delayed Sampling), Irradiated EA015V00, EA016V00, EA017V00, EA018V00 5 5 10 7 Platelets, PAS LVDS (Large Volume Delayed Sampling) EA136V00, EA137V00, EA138V00, EA139V00 55 10 65 8 Platelets, PAS LVDS (Large Volume Delayed Sampling) Irradiated EA152V00, EA153V00, EA154V00, EA155V00 25 5 30 9 Frozen Plasma (Frozen within 24 hours) E2555V00, E7644V00, E7646V00, E7648V00 300 20 320 10 Cryoprecipitate AHF Pooled E3587V00 65 1 66 11 Granulocyte, Apheresis E3673V00 1 1 2 12 Platelet Crossmatch testing, Neutrophil Lab N86022 5 5 10 13 RBC Ag Neg 1 per unit A41 50 12 62 14 ABO Type 86900 10 15 25 15 RH Type 86901 15 10 25 16 Antibody Screen 86850 5 25 30 17 Antibody Identification 86870 50 20 70 18 Antibody Elution 86860 10 10 20 19 DAT, each antiserum 86880 20 20 40 20 RH phenotype complete 86906 10 5 15 21 Differential Adsorption of serum 86978 50 5 55 22 Call Charge weekends, Holidays NA 10 15 25 23 IRL After Hours Fee NA 10 10 20 24 Unscheduled shipping - customer initiated (ASAP) N/A 300 52 352 25 STAT shipping - customer initiated N/A 180 52 232 26 Neutrophil Antibody ID 86021 10 1 11 27 HLA Antibody Screen HLA025 7 3 10 28 Platelet Antibody Screen-HLA Testing HLA04 7 5 12 29 Platelet Antibody Screen-Neutrophil NEU04 5 5 10 30 AB PLASMA SURCHARGE B3M 40 5 45 31 Misc. Emergency Blood Products or Testing Services N/A 1 1 2 32 Liquid Plasma E2457V00, E2463V00, E2469V00 70 1 71 33 RBC Ag, other than ABO or D N01786905 20 10 30 34 Pre-Rx RBC/chemicals/Drugs N01786970 30 10 40 35 Rare/uncommon Pheno/unit N017F51 15 4 19 36 RBC Ag neg 2 per unit N017B41 10 10 20 37 RBC Ag neg 4 per unit N017D41 5 5 10 38 Platelet Antibody ID NEU08 4 1 5 39 HEA Panel Testing SREF-IVD 1 10 11 40 Cold Agglutinin Screen N01786156 1 1 2 41 STAT Ag order non-rtn hrs N017S4I 5 0 5 42 STAT Ag Order Routine hrs N017R41 5 5 10 43 RBC Ag neg 3 per unit N017C41 12 0 12 Specifications of Contractor: All blood products offered must be provided from a blood bank that 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 U.S.C. Section 260. The contractor must make paper copies available to both MVAHCS and SCVAHCS of the Circular of Information for the Use of Human Blood and Blood Components , which, by FDA regulation, must be available to all prescribing physicians. The Contractor must submit proof that it holds 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 U.S.C. Section 262, as a source of supply for biological products. Contractor must provide products from blood banks that are able to provide both MVAHCS and SCVAHCS with 100% volunteer donor blood in accordance with FDA rules and regulations. Definition of a volunteer donor - A volunteer donor is a 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. The contractor and its health-care providers will be liable for their liability-producing acts or omissions. The contractor will maintain or require all health-care providers performing under this contract to maintain, during the term of this contract, professional liability insurance issued by a responsible insurance carrier of not less than the following amounts, per specialty, per occurrence: One million dollars, unless the contractor is an entity or subdivision of a State that either provides for self-insurance or limits the liability of the amount of insurance purchased by State entities, then the insurance requirement of this contract will be fulfilled by incorporating the provisions the applicable State law. The Contractor, upon request of the contracting officer, prior to contract award, will furnish evidence of the insurability of the Contractor and/or of all health-care providers who will perform under this contract. The submission will provide evidence of insurability concerning the medical liability insurance required as described above or the provisions of State law as to self-insurance, or limitations on liability or insurance. The Contractor must provide Certificates of Insurance or insurance policies evidencing the required insurance coverage and an endorsement stating that any cancellation or material change adversely affecting the Government s interest will not be effective until 30 days after the insurer or the contractor gives written notice to the contracting officer. Certificates or polices will be provided for the contractor and/or each health-care provider who will perform under this contract. The contractor must notify the contracting officer, or any of the health-care providers performing under this contract, of any change in insurance providers during the performance period of this contract. The notification will provide evidence that the contractor and/or health-care providers will meet all the requirements of this clause, including those concerning liability insurance and endorsements. These requirements may be met either under the new policy, or a combination of old and new polices, if applicable. The contractor must obtain all necessary licenses and/or permits required to performed work described in this contract. Contractor will take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. The contractor will be responsible for any injury to himself/herself, his/her employees, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by his/her employee s fault or negligence, and will maintain personal liability and property damage insurance having coverage for a limit as required by the laws of the State of Minnesota. Further, it is agreed that any negligence of the Government, its officers, agents, servants and employees, will not be the responsibility of the contractor here under with the regard to any claims, loss, damage, injury, and liability resulting there from. Contractor must present evidence of their technical capability to provide blood products which pass acceptable standards for blood banks per the Association for the Advancement of Blood and Biotherapies (AABB). The contractor must be accredited by the Association for the Advancement of Blood and Biotherapies (AABB), Food and Drug Administration (FDA) and Clinical Laboratory Improvement Amendments (CLIA) and must supply proof with proposal. Upon request, the contractor must provide evidence of their quality process, proficiency testing, and surveillance by accreditation agencies. Collection Requirements: Minimum collection requirements contractor must follow: All blood products are to be collected by the closed system under aseptic conditions and will be processed in appropriate solutions and the container so labeled. A sample of blood from each donation will be tested for infectious diseases and all testing shall comply with current AABB Standards 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 marker prior to shipment, except with the express written authorization of the VA Blood Bank Medical Director or his/her designee. The contractor will utilize methods to limit introduction of bacteria during collection and processing of blood products, in accordance with current AABB Standards. Each platelet component must be tested for bacterial contamination using a FDA approved commercial detection system, or use pathogen reduction technology, in accordance with current AABB Standard. The contractor will immediately notify MVAHCS and/or SCVAHCS if subsequent testing indicates the supplied platelets may be contaminated with bacteria. Donor Requirements The contractor will ensure that all donor and blood component records are identified and traceable. Donor selection must be in accordance with criteria established by the FDA and AABB. The contractor will maintain available blood donor lists, including names, addresses, and social security numbers. Such lists must indicate whether, and on what date, blood of a particular donor was furnished to MVAHCS and SCVAHCS under this contract. Under no circumstances will the contractor ever reveal the identity of the blood donor. Contractor s donor identification numbers must be unique to the donor unit and must have a FDA approved numbering schematic. Each voluntary donation must be minimally tested for the following infectious diseases: Hepatitis B Surface antigen (HBsAg) Antibodies to hepatitis B core (anti-HBc) Antibodies to hepatitis C (anti-HCV) Antibodies to human immunodeficiency virus, type 1 and type 2 (anti-HIV1 and anti-HIV2) Antibodies to human T lymphotropic virus type 1 and type 2 (anti-HTLV-1 and anti-HTLV-II) Genetic viral material to detect HIV type 1 and HCV by nucleic acid amplification Syphilis Zika Babesia Minimum Labeling Blood Product Requirements: All blood products will be typed and labeled for ABO and Rh antigens in accordance with methods recommended in the current AABB Standards and Technical Manual. All labels on blood products must be compatible with both MVAHCS and SCVAHCS VBECS systems. The label will also indicate 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. ISBT-128 labeling must be used on all blood products offered to both MVAHCS and SCVAHCS. Ordering methods and procedures: Contractor shall define the preferred method of ordering. If preferred method is a web-based portal or computer-based ordering system of any type, implementation is dependent on being found acceptable for use by the ISO (Informational Security Officers) in the VA Healthcare System. If deemed unacceptable for use, there will be no extra charges that incur to the Government for an alternative process of ordering. (For Contractor to fill out): Contractor s preferred method of ordering: __________________________________________ A back up method of placing the order via telephone must be readily available in the instance the preferred method will not work. (For Contractor to fill out) Contractor s point of contact: ___________________ Contractor s Telephone Number for ordering: Contractor s Telephone Number for issues with Ordering: ___________________________ Standing Orders: MVAHCS and SCVAHCS will establish standing orders with the contractor for various blood products. Multiple standing orders can be established at no additional cost to the Government, if necessary. Contractor must be flexible with making adjustments to the standing order(s) if requested by either location. Routine, ASAP, or STAT orders: MVAHCS and SCVAHCS will place additional orders stating the products and quantities on an on-demand, as needed basis via the contractors preferred or backup ordering method. Urgency of order will be determined by each location. MVAHCS and SCVAHCS laboratory personnel may need to place orders twenty-four hours a day, seven days per week. Names of lab personnel authorized to place, accept, or reject orders will be provided to the contractor upon request. Packaging, Shipping, and Delivery Time Requirements: Packaging for delivery: All blood products delivered under this contract will 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 the contractor s place of business and both MVAHCS and SCVAHCS. Red blood cells: Proper in-transit temp is +1C to +10C, packaged with wet ice. Platelet Products: Proper in-transit temp is +20C to +24C. Frozen Products: Must maintain frozen state. Blood products must be collected, stored, prepared, tested, and shipped in accordance with FDA regulations, AABB Standards, and U. S. Department of Transportation (DOT) requirements. Shipping: Contractor will be responsible for providing courier service to transport blood products to each VA location and pick-up blood product returns, extra boxes, and specimens for reference laboratory testing. Courier service must be available 24/7/365. Contractor will make a minimum of one scheduled delivery per week to SCVAHCS and daily scheduled deliveries to MVAHCS, Sunday through Saturday, excluding Federal holidays, between the hours of 0700 and 1500 CST. Additional scheduled deliveries may be added at no additional cost to the Government, if necessary, through mutual agreement between contractor and site. The contractor must be able to provide additional deliveries for orders that cannot wait until the next scheduled delivery. Contractor will define expected delivery times based on order type. Minneapolis Address/Hours: Minneapolis Laboratory Blood Bank Room BB-145 One Veterans Drive Minneapolis, Minnesota, 55417 Hours: 24 hours per day, 7 days per week, 365 days per year St. Cloud Address/Hours: St. Cloud Laboratory Building 1 Basement 4801 Veterans Drive St. Cloud, MN 56303 Hours: Mon-Fri, 6am-6pm Delivery time requirements: Standing orders: planned and recuring deliveries will be made at mutually agreed upon day(s) between contractor and both MVAHCS and SCVAHCS. Routine orders: deliveries will be made on the next scheduled delivery day. Each location will be flexible with routine orders to accommodate local transfusion needs. ASAP orders: products will be out the door within 4 hours of order STAT orders: products will be out the door within 1 hour of order. Delivery time is variable but shall not exceed 1.5 hours for both MVAHCS and SCVAHCS. Blood must be available twenty-four hours per day, seven days per week. Once units are received at both MVAHCS and SCVAHCS, those units become their property, and payment will be made appropriately, based on contract terms and proper invoicing. For inventory control purposes, efforts will be made by both MVAHCS and SCVAHCS to assist the contractor and other facilities in meeting patient transfusion needs. Products may be transferred to and from other local hospitals as long as both sites are serviced by the same contractor and contractor is in agreement with the transfer arrangements. In the event contractor does not service any local hospitals for MVAHCS or SCVAHCS, contractor must supply STAT blood products at no additional cost to the Government, allow rotation of blood product inventory (to include at minimum red blood cells and platelets), and meet the delivery time requirements. Acceptance and Rejection Criteria for Blood Products: All blood components will be labeled, stored, and shipped in accordance with the current regulations of the FDA, AABB and DOT. In the event these regulations change during the contract, the contractor will implement the necessary changes as directed/recommended by the regulatory and accrediting agencies. The contractor must notify both sites of any changes. All blood products supplied will be grossly free of hemolysis, excessive chyle, and clots. Additional criteria for red blood cells: The individual units must be visually inspected for any abnormality in color or physical appearance and for any indication of microbial contamination. If evidence exists, the units will not be accepted into inventory. Units must have at least four segments remaining. Additional criteria for platelet products: The individual units must be visually inspected for any abnormality in color or physical appearance and for any indication of microbial contamination. If evidence exists the units will not be accepted into inventory. Shelf life of blood products that will be found acceptable: For routine orders, allogeneic blood/blood components must be supplied with appropriate remaining shelf life, as detailed below: Whole Blood: Shelf life more than 21 calendar days, regardless of anti-coagulant Red Blood Cells: Shelf life more than 21 calendar days, regardless of anti-coagulant Fresh Frozen Plasma: Shelf Life more than 60 calendar days Platelets (random): Shelf life more than 48 hours Cryoprecipitate: Shelf life more than 60 days Credit for Returned or Rejected Blood Products: Credit will be given when blood is delivered to either MVAHCS or SCVAHCS with a shelf life of 10 days or fewer. The contractor may contact either MVAHCS or SCVAHCS if the only product available has a short shelf life, and it is the only blood available to meet the patient s needs. The VA can determine whether to accept or reject the blood available to meet the patient s needs. The contractor will provide credit for products that are put into quarantine at their direction, which either expire while in quarantine, or if MVAHCS or SCVAHCS is unable to use due to the extended time the products were out of circulation. When blood products do not meet the acceptance criteria of MVAHCS or SCVAHCS. Acceptance criteria may be based on abnormalities in physical appearance, indications of contamination, product temperature on receipt, and other criteria regarding the quality or acceptability of blood products. Full credit will be given for frozen plasma that ruptures during thaw. Contractor will make an effort to work with both MVAHCS and SCVAHCS to return red blood cells to rotate stock and avoid components from expiring on the shelf. Credit shall be given. Vendor shall provide minimum return requirements such as minimum days until expiration and minimum remaining segments. Recalled and Defective Products: The contractor will immediately notify the affected MVAHCS or SCVAHCS when information is discovered indicating that a blood product may not be considered safe. As appropriate, the contractor will replace and/or reimburse recalled/defective products at no cost to the government. With respect to blood manufactured by the contractor, contractor will provide the following notifications to MVAHCS and/or SCVAHCS. Within 3 calendar days if blood collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection. Within forty-five (45) calendar days of the test, the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by the FDA As set forth in 21 C.F.R 610.46-610.48. TRALI Risk Reduction Strategies: Transfusion-related acute lung injury (TRALI) is a major cause of transfusion-related morbidity and mortality. The contractor will implement all published AABB recommendations and Standards regarding donor management strategies to reduce the risk of TRALI, and must inform MVAHCS and SCVAHCS in writing of any changes to their TRALI risk reduction plan. An updated risk reduction plan will be sent to each site annually. Reporting of Adverse Transfusion Events: MVAHCS and SCVAHCS will keep complete and accurate records, as required by law, of patients transfused with any blood products. Both MVAHCS and SCVAHCS will report any possible transfusion-transmitted infections or other serious complications associated with transfusion to the contractor. Both MVAHCS and SCVAHCS will co-operate with the contractors investigation of any adverse event and supply information concerning the recipient of the blood product to the contractor on forms provided by the contractor. Patient information will only be shared if deemed necessary by the AABB, FDA, or Department of Health regulations. In this event, either the MVACHS or SCVAHCS privacy officers may need to provide written approval. Immunohematology Reference Laboratory Services: Availability and turn around times: Immunohematology Reference Laboratory (IRL) Services for red cell antibody identification must be available twenty-four hours per day, seven days per week, and must provide test results and antigen negative blood products within twenty-four hours for urgent clinical situations, and within forty-eight hours in non-urgent situations. The reference laboratory must keep MVAHCS and SCVAHCS informed if the required testing is going to exceed the listed timeframe. Tests that will be performed are specified in the 1.A Schedule of Items section. Government Roles and Responsibilities: The MVAHCS and SCVAHCS shall designate a Technical Representative to coordinate and monitor the work to be completed under this contract. Contact information is listed below. Technical Representatives: (To be given at award.) Performance Measures: The following performance measures will be regularly tracked and monitored throughout the effective period of this contract by the MVAHCS Technical Representative and reported to the Contracting Officer. Acceptable performance on these measures, along with other factors, will be primary indices of contractor performance and a key consideration in contract renewal decisions. Performance will be monitored using the following criteria: Task Indicator Standards Acceptable Quality Levels Method of Surveillance Incentive IRL Support Contractor must provide contact information for the IRL which must be available 24 hours a day, 7 days a week. Qualified contractor IRL personnel must be available 24 hours a day, 7 days a week. 100% MVAHCS and SCVAHCS staff will report any occurrences where they were unable to contact the IRL when necessary. Favorable Contractor Performance evaluation Shipment and delivery time of STAT orders Contractor must ship STAT orders within 1 hour of order and deliver no longer than 1.5 hours after shipping. Exceptions will be made for weather delays, but vendor needs to show an effort to meet our need. STAT orders must be shipped within 1 hour of order and delivered no longer than 1.5 hours after shipping. 100% MVAHCS and SCVAHCS staff will report to the COR any occurrences where STAT orders were not shipped within 1 hour of order or delivery took longer than 1.5 hours after shipping. Favorable Contractor Performance evaluation Invoicing Contractor must submit invoices in a timely manner, after each billing week. Invoices must be submitted electronically through Tungsten. All invoices are itemized, have the correct PO number listed, and reflect contract pricing. 100% Inspection and review by COR, each invoice. Favorable Contractor Performance evaluation