6506--Blood & Blood Products RFI

Responses must be received no later than Monday, August 19, 2024, at 10:00AM EST. THIS REQUEST FOR INFORMATION (RFI) IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI IN ACCORDANCE WITH (IAW) FAR 15.201(e). DISCLAIMER: This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW 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 associated with responding to this RFI. SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a sources sought/RFI only. The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 621991. Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 5 Network Contracting Office, is seeking sources that can provide Blood & Blood Products for the Clarksburg VA Medical Center. ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 250.00 EA __________________ __________________ Red Cells AS-1 500mL LeuRed LOCAL STOCK NUMBER: E0336V00 0002 2.00 EA __________________ __________________ Plts Aph ACD-A PASC LeuRed PathRed Cnt1 LOCAL STOCK NUMBER: E8341V00 0003 5.00 EA __________________ __________________ Plts Aph ACD-A PASC LeuRed PathRed Cnt2 LOCAL STOCK NUMBER: E8342V00 0004 1.00 EA __________________ __________________ Plts Aph ACD-A PASC LeuRed PathRed Cnt3 LOCAL STOCK NUMBER: E8343V00 0005 16.00 EA __________________ __________________ Plasma <24h CPD LOCAL STOCK NUMBER: E2555V00 0006 154.00 EA __________________ __________________ SHP-Scheduled/Routine LOCAL STOCK NUMBER: A8B 0007 15.00 EA __________________ __________________ SHP-Unscheduled LOCAL STOCK NUMBER: J8B 0008 8.00 WK __________________ __________________ STAT Processing Fee LOCAL STOCK NUMBER: Y8B 0009 45.00 EA __________________ __________________ HEMOGLOBIN S, PER TEST LOCAL STOCK NUMBER: 85660 0010 2.00 EA __________________ __________________ Unit W/1 Empty Bag Att (EMP1) LOCAL STOCK NUMBER: 88201 0011 72.00 EA __________________ __________________ Anti-CMV negative LOCAL STOCK NUMBER: 88801 0012 27.00 EA __________________ __________________ IRLINV LOCAL STOCK NUMBER: 88818 0013 13.00 EA __________________ __________________ GENINV LOCAL STOCK NUMBER: 88819 0014 3.00 EA __________________ __________________ GENINV2 LOCAL STOCK NUMBER: 88820 0015 2.00 EA __________________ __________________ COLD AGGLUTININ SCREEN LOCAL STOCK NUMBER: 86156 0016 4.00 EA __________________ __________________ ANTIBODY SCREEN, EACH MEDIA LOCAL STOCK NUMBER: 86850 0017 2.00 EA __________________ __________________ ELUTION, EACH LOCAL STOCK NUMBER: 86860 0018 21.00 EA __________________ __________________ AB ID/EACH PANEL & MEDIA LOCAL STOCK NUMBER: 86870 0019 15.00 EA __________________ __________________ DAT, EACH ANTISERA LOCAL STOCK NUMBER: 86880 0020 6.00 EA __________________ __________________ AB ID/EACH SELECTED REAGENT CELL LOCAL STOCK NUMBER: 86885 0021 7.00 EA __________________ __________________ ABO TYPE LOCAL STOCK NUMBER: 86900 0022 7.00 EA __________________ __________________ RH TYPE LOCAL STOCK NUMBER: 86901 0023 22.00 EA __________________ __________________ RBC AG, OTHER THAN ABO OR D, EACH LOCAL STOCK NUMBER: 86905 0024 10.00 EA __________________ __________________ Pre-Rx RBCs w/chemicals/drugs, per cell LOCAL STOCK NUMBER: 86970 0025 11.00 EA __________________ __________________ RBC Ag neg 1 per unit LOCAL STOCK NUMBER: A4I 0026 2.00 EA __________________ __________________ RBC Ag neg 2 per unit LOCAL STOCK NUMBER: B4I 0027 2.00 EA __________________ __________________ Rare/uncommon pheno/unit LOCAL STOCK NUMBER: F5I 0028 1.00 EA __________________ __________________ Ag Screen-pt serum/unit LOCAL STOCK NUMBER: H5I 0029 1.00 EA __________________ __________________ Ag scrn, spec order 1-10 LOCAL STOCK NUMBER: J4I 0030 11.00 EA __________________ __________________ Imm Sp Crossmatch; 86920 LOCAL STOCK NUMBER: M5I 0031 11.00 EA __________________ __________________ AGT phase of Xmat; 86922 LOCAL STOCK NUMBER: O5I 0032 1.00 EA __________________ __________________ STAT Ag order routine hrs LOCAL STOCK NUMBER: R4I 0033 7.00 EA __________________ __________________ IRL CASE TRACKING CODE LOCAL STOCK NUMBER: REF10 0034 2.00 EA __________________ __________________ Sample referral call-in fee, per hour LOCAL STOCK NUMBER: REF31 0035 3.00 EA __________________ __________________ STAT IRL sample non-rtn hours LOCAL STOCK NUMBER: REF33 0036 3.00 EA __________________ __________________ STAT Ag order non-rtn hrs LOCAL STOCK NUMBER: S4I 0037 1.00 EA __________________ __________________ STAT IRL sample, routine hours LOCAL STOCK NUMBER: V4I 0038 1.00 EA __________________ __________________ 0001U-xHEA licensed RBC panel LOCAL STOCK NUMBER: SREF-IVD 1001 0.00 __________________ __________________ Blood and Blood Products Contract Period: Option 1 POP Begin: 10-01-2025 POP End: 09-30-2026 2001 0.00 __________________ __________________ Blood and Blood Products Contract Period: Option 2 POP Begin: 10-01-2026 POP End: 09-30-2027 3001 0.00 __________________ __________________ Blood and Blood Products Contract Period: Option 3 POP Begin: 10-01-2027 POP End: 09-30-2028 4001 0.00 __________________ __________________ Blood and Blood Products Contract Period: Option 4 POP Begin: 10-01-2028 POP End: 09-30-2029 GRAND TOTAL __________________ Statement of Work for Blood and Blood Products and Serological Workup Services D.1. Scope: The contractor shall provide suitable blood, blood components, fractions, and derivatives to meet the transfusion needs of patients under treatment at the Louis A. Johnson Veterans Administration Medical Center, 1 Medical Center Drive, Clarksburg, WV, 26301 in strict accordance with this contract. The contractor shall also provide serological workup services including Antigen Testing on blood products and patient blood samples, ABO/Rh testing, Antibody Screen and Antibody Identification Testing, Direct Antiglobulin Testing, and perform Autoabsorptions, Eluates, and Compatbility Searches as requested by the Louis A. Johnson Veterans Administration Medical Center, 1 Medical Center Drive, Clarksburg, WV, 26301. The expected period of performance for implementation will be October 1, 2024 thru September 30, 2025 with the possibility of five (5) 12-month options for extended support and deliveries. This is a firm-fixed-price contract. D.1.1. Acronyms: CO Contracting Officer; COR Contracting Officer s Representative; Blood Supplier Contractor; CLIA Clinical Laboratory Improvement Amendments; AABB American Association of Blood Banks; FDA Food and Drug Administration; VA Veterans Administration; ISBT International Society of Blood Transfusion; D.1.2. Accreditation: Blood Supplier must hold a current certification of accreditation under CLIA 88, be accredited by the AABB, and must be registered with the FDA. All blood supplier policies and procedures must meet the requirements of the current FDA good manufacturing procedures and the current edition of the AABB Standards for Blood Banks and Transfusion Services. Noncompliance issues cited on FDA and AABB inspections must be addressed and corrected. D.1.3. Volunteer Donors: Only blood from volunteer donors can be utilized. D.1.4. Labeling: All blood and blood products must be labeled using ISBT Code 128 bar code symbology. D.1.5. Autologous Donations: Blood Supplier must provide a means for patients to undergo autologous pre-operative donations, whether at the VA Medical Center or at a blood center supplying other blood components to the VA Medical Center. The patient s healthcare provider is responsible for ensuring patient safety and advising against autologous donation if physical risks to the patient are evident. D.1.6. Directed Donations: Blood Supplier must provide a means for family and friends of VA Medical Center patients to donate units of blood or blood components to be transfused to a specific patient, although VA policy discourages designating specific units of blood or components for transfusions for a specific patient. D.1.7. Pheresed Products: Blood Supplier must be able to provide both Platelet and Fresh Frozen Plasma blood components prepared by automated apheresis procedures. D.1.8 Pre-Pooled Products: Blood Supplier must be able to provide pre-pooled Cryoprecipitate products as requested by the VA Medical Center. D.1.9. Lookback / Consignment Notifications: Blood Supplier must notify the VA Medical Center when a donor who has previously tested negative for markers of transfusion transmitted diseases tests positive for any marker. Blood Supplier must also notify VA upon discovery of donor s inaccurate response to any questions resulting in permanent or temporary deferral. Information must include unit identification numbers and shipment dates of any units shipped to the VA Medical Center. D.1.10. Definitions: (a) Blood: includes blood, blood components, fractions, and coagulation derivatives. It does not include albumin or other derivatives. (b) ISBT 128: Bar code labeling specification based on Code 128. (c) Code 128: A bar code symbology. (d) Turnaround Time: Turnaround time is determined by comparing Date/Time of request for blood with the date/time of delivery as documented on the shipping manifest. (e) STAT: Blood must be delivered within two hours of request unless irradiated or antigen-negative blood products are requested. (f) Target Inventory: The minimum number of units of red blood cell containing products and fresh frozen plasma available for transfusion by the VA Medical Center. D.2. Delivery of Blood: Blood Supplier will have the ability to provide blood product deliveries 24 hours a day, seven days a week. Blood will be as fresh as possible but not over fifteen days old. D.2.1 Standing Blood Inventory (Target Blood Inventory): The VA Medical Center maintains a Target Inventory of leukoreduced red blood cells and fresh frozen plasma. The Blood Supplier must be able to support, at a minimum, the following requirements for daily inventory: Leukoreduced Red Blood Cells: O Positive 10 units O Negative 4 units A Positive 0 units A Negative 4 units B Positive 0 units B Negative 0 units AB Negative 0 units AB Negative 0 units (c) Fresh Frozen Plasma: Group O 2 units Group A 8 units Group B 0 units Group AB 2 units D.2.2 Communication of Delivery Needs: Blood Supplier will provide a mechanism for verbal and written communication to document the VA Medical Center s requests for blood and blood products. Examples of written communication include facsimile or electronic mail. If requested by the Blood Supplier, the VA Medical Center will provide a written daily inventory of leukoreduced red blood cells and fresh frozen plasma, along with the delivery order for the day. D.2.3 Delivery Schedule: A standing delivery schedule of not less than 3 deliveries per workweek (Monday, Wednesday, Friday) must be available to maintain Target Inventory levels. With the exception of STAT and nonscheduled deliveries and deliveries of platelets and cryoprecipitate, blood products shall be delivered with an expiration date of no less than 10 days from the date of delivery. D.2.4. Nonscheduled Deliveries: Blood Supplier must be able to provide deliveries of requested blood outside of the standing delivery schedule as needed. D.2.5. Emergency (STAT) Deliveries: Blood Supplier must be able to provide deliveries of blood on an emergent (STAT) basis. STAT requests must be delivered within two hours unless the requested product is irradiated or antigen-negative. D.2.6. Turnaround Time (TAT): Deliveries will be made in accordance with the indicated timetable. a. Stat Requests within 2 hours b. Scheduled Deliveries 2 5 hours c. Nonscheduled Deliveries 1 - 5 hours D.3. Quality Control: The contractor shall meet the following timeliness and accuracy rates: D.3.1. The Contractor shall implement and maintain a quality control (QC) system that results in correction of potential and actual problems throughout the entire scope of contract performance. The QC system shall contain a mechanism for corrective actions without dependence upon government direction. Records of all Contractor QC activities shall be maintained during the life of the contract. D.3.2 The Contractor shall maintain a quality standard of 95% accuracy. Percentage is based on ratio of errors to deliveries. (Example: 60 deliveries/quarter, 3 errors: 3/60=0.05 or 5% errors. Accuracy is 95%.) Errors are considered to be: a. Wrong blood product received b. Wrong ABO/Rh of blood product received c. Unavailability of requested product for more than 6 hours d. Inability to deliver requested product within required timeframe D.3.3. Each delivery necessitated to correct a delivery of incorrect or inadequate blood products shall be at no cost to the Government. D.3.4. Deliveries lost or damaged by the Blood Supplier shall be redone at no additional charge to the Government. The Blood Supplier shall send a letter to the COR and VA Medical Center Blood Bank Lead Technologist stating that the delivery was lost and give the reason. D.3.5. Deliveries that do not meet the TAT due to errors or omissions on the part of the VA and which are not correctable by the Blood Supplier are not counted against the contractor's performance. D.3.6 In the event the Blood Supplier experiences a problem in making a delivery, e.g. delay in availability of requested product, delay in availability of driver to transport product within requested timeframe), the Contract Manager shall immediately contact the COR and identify the problem. The COR shall attempt to resolve problems as they arise. D.4. Equipment: D.4.1 The Blood Supplier shall provide a direct means for VA Medical Center personnel to contact a personal representative of the Blood Supplier 24/7 for the purposes of ordering blood. Personal contact is required for emergency and nonscheduled orders. D.4.2. The Blood Supplier shall provide all transport containers, coolers, supplies and equipment to maintain the transit temperature of blood and blood components within the limits required by the American Association of Blood Banks. D.5. Privacy Act: The Blood Supplier shall comply with the provisions of the Privacy Act of 1974, HIPAA and all applicable VA laws and regulations. Additional information to identify the patient and type of blood product or service needed will be provided by the VA Medical Center Blood Bank as needed. The Blood Supplier shall not maintain, in any form, any sensitive or patient identified information except as required by the FDA or AABB. The Contractor shall comply with the Privacy Act and HIPAA as it pertains to general patient information, HIV, Drug and Alcohol Abuse, and Sickle Cell Anemia. The Contractor shall have plant security and ADP security necessary to safeguard VA records. D.6. Billing/Invoice: Billing shall be made monthly in arrears. At least partial credit (e.g. less NAT fee) must be given for all products returned by the VA Medical Center to the Blood Supplier in transfusable condition with less than fifteen days left on the expiration of the product. Invoices shall provide sufficient detail to enable comparisons of billed units to the typed reports. D.7. Contractor s Training and Quality Assurance Plans: Contractor shall maintain an ongoing Training Plan and Quality Assurance Plan. VA reserves the right to periodically review training records for contractor's staff assigned to this contract, receive written documentation of any on-going quality improvement training provided to staff, and review copies of quality monitors performed on VA reports. D.8. Phase-In Plan: The contractor shall submit a phase-in plan for the transition period between contract award and live production. Transition from contract award to full performance shall not exceed 45 days. D.9. Contingency Services: Contractor shall maintain adequate resources necessary to ensure that delivery services for the VA are uninterrupted regardless of contingency or circumstance. D.10. SPECIAL CONTRACTOR RESPONSIBILITES: The contractor shall designate a primary and alternate point of contact by name and phone number who will function as liaison with the COR on day-to-day operations, and will be available from 8:00 am EST to 4:30 pm EST Monday through Friday, excluding Federal Holidays. The Contractor shall designate a company officer authorized to resolve ongoing problems that have not been resolved at the operations level. Closeout Deadlines: VA is required to meet monthly closeout deadlines, which require that all invoices be certified for payment within 10 calendar days. The contractor shall ensure that VA does not fail to meet this deadline due to contractor failure to meet the contract TAT. D.11. SPECIAL GOVERNMENT RESPONSIBILITIES: 1. Advance notification whenever possible regarding workflow fluctuations or other changes that impact contractor performance. 2. Regular meetings at monthly or other increments, as mutually agreed upon between the VA and the contractor. D.12. CONTRACT ADMINISTRATION: Communication Points: Day to day communication between both contract parties occur between the VA COR (see next section for designation) and the contractor's primary or alternate operations manager. Problems unresolved at this level will be referred to the VA contracting officer and the contractor's designated corporate officer. Payments: The Blood Supplier shall submit monthly invoices showing the number of units delivered, the number of units returned, and enumerated charges for all other services. The Blood Supplier will submit invoices by the 10th calendar day each month. Contractor may set any schedule of work hours for its employees performing work at its own facility under this contract providing the VA's TAT requirements will be met; however, the contract price stated in schedule B is considered payment in full for all services rendered under this contract. D.13. SECURITY: C&A requirements do not apply, and a Security Accreditation Package is not required. Place of Performance: Department of Veterans Affairs 1 Medical Center Drive Clarksburg WV 26301 ____________________________________________________________________________ The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications. If you are interested and are capable of providing the sought-out supplies/services, please provide the requested information as well as the information indicated below. If you are interested and are capable of providing the sought-out supplies/services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc. (2) Is your company considered small under the NAICS code identified under this RFI? (3) Are you the manufacturer or distributor of the items being referenced above (or equivalent product/solution)? What is the manufacturing country of origin of these items? (4) If you are a small business and you are an authorized distributor/reseller for the items identified above (or equivalent product/solution), do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (5) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract type and number. (6) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the referenced items/solutions available on your schedule/contract? (7) Please provide general pricing for your products/solutions for market research purposes. (8) Please submit your capabilities in regard to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes? *** Submissions addressing Section (8) should show clear, compelling, and convincing*** evidence that all equal to items" meet all required salient characteristics. Responses to this notice shall be submitted via email to contact@example.gov. Telephone responses shall not be accepted. Responses must be received no later than Monday, August 19, 2024, at 10:00AM EST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this request for information. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation.