SPECIAL NOTICE
66 -- Ortho Vision Analyzers and Reagents
- Notice Date
- 5/5/2022 2:48:14 PM
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- 244-NETWORK CONTRACT OFFICE 4 (36C244) PITTSBURGH PA 15215 USA
- ZIP Code
- 15215
- Solicitation Number
- 36C24422I0583
- Archive Date
- 06/04/2022
- Point of Contact
- Amanda Saunders, Contracting Officer, Phone: 412-822-3731
- E-Mail Address
-
amanda.saunders@va.gov
(amanda.saunders@va.gov)
- Awardee
- null
- Description
- SOURCES SOUGHT NOTICE 36C244I0583 MARKET RESEARCH PURPOSE ONLY This is a SOURCES SOUGHT NOTICE only. Responses to this notice will be used for information and planning purposes. No quotes are being requested or accepted at this time with this notice. The Department of Veterans Affairs has a VISN 4 requirement for Ortho Vision Analyzers & Reagents. The North American Industry Classification System (NAICS) code being considered for this procurement is 334516- Analytical Laboratory Instrument Manufacturing and the Product Service Code (PSC) is 6630 Chemical Analysis Instruments. Below is a draft copy of the Statement of Work (SOW). Responses to this notice should include the following: Company name Data Universal Numbering System (DUNS) number Company s address Point of Contact information (i.e. title, phone number and email address) Company s capability to meet this requirement and any pertinent information which demonstrates the company s ability to meet the above requirements. GSA Federal Supply Schedule contract number, if within scope of this effort (if applicable). Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner? Yes ___No ___ If yes, please identify which companies are considering a Joint Venture and the ownership of each company. Company s type of business (small or large) and socioeconomic status whether Service Disable Veteran Owned, Veteran Owned, Hubzone, 8(a), Women Owned, Small Disadvantaged, etc. If applicable, Service-Disabled Veteran Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) must be verified in www.VetBiz.gov , and be able to meet the limitation on subcontracting in accordance with 13 CFR 125.6; if applicable. All responses shall be submitted in writing via email no later than 12 Noon EST, on March 9th, 2022 to Mrs. Amanda Saunders at Amanda.Saunders@va.gov SUBJECT LINE: Ortho Vision Analyzers & Reagents E-mail: Amanda.Saunders@va.gov. Facsimile or telephonic responses will not be accepted. Simply responding as an interested party in beta.SAM.gov does not constitute your company as a source. Offeror must provide the above requested information. After review of the responses to this sources sought notice, a solicitation announcement may be published in the near future. Responses to this sources sought announcement are not considered adequate responses to the solicitation announcement. All interested offerors will have to respond to the forthcoming solicitation announcement, in addition to responding to this sources sought notice. All interested parties must be registered with System for Award Management (SAM) at beta.SAM.gov in order to be eligible for award of Government contracts. STATEMENT OF NEED Lebanon VA Medical Center Title of Project: Ortho-Clinical Diagnostics, Inc. Analyzers, Reagents and Quality Control for Blood Bank Analysis Background: The Lebanon Veterans Affairs Medical Center (LVAMC) has been utilizing Ortho Clinical Diagnostics equipment and reagents since 2015. A new laboratory is being developed for Clinical Support and is tailored to meet the specifications of the Ortho VISION Analyzer and supporting equipment. The laboratory staff is fully trained on the Ortho Clinical Diagnostics equipment and processing of supplies. Additionally, the current Ortho VISION Analyzer is due for lifecycle replacement, and it is in LVAMC s best interest to procure a cost by test contract that includes the Analyzers and supporting equipment. Scope of Work: This action is for a sole source acquisition with Ortho Clinical Diagnostics for a firm fixed-priced, indefinite-delivery indefinite-quantity (IDIQ) Cost Per Reportable Test contract. The contractor must deliver and install two (2) FDA approved Ortho Clinical Diagnostics VISION Analyzers with Warranty, Sample Racks, and two (2) Ortho VISION Tables, drain kits, and printers. The contractor must provide recurring monthly deliveries of Ortho-Clinical Diagnostics testing reagents and quality control for the periods outlined in this statement of work through coordination with the LVAMC Contracting Officer Representative (COR). Delivery must be within 30 days from the contract award date in coordination with the COR to the Lebanon Veterans Affairs Medical Center, 1700 S. Lincoln Ave., Lebanon, PA 17042. Period of Performance: The period of performance is a base plus four (4) task order indefinite-delivery indefinite-quantity (IDIQ) Cost Per Reportable Test contract, with a starting date of June 27, 2022 and an ultimate end date of June 26, 2027. Base Year June 27, 2022 June 26, 2023 Task Order 1 June 27, 2023 June 26, 2024 Task Order 2 June 27, 2024 June 26, 2025 Task Order 3 June 27, 2025 June 26, 2026 Task Order 4 June 27, 2026 June 26, 2027 General Requirements: Equipment- The Lebanon VA Medical Center has a need for two (2) Ortho Clinical Diagnostics VISION Analyzers. The new analyzers must meet the unique needs of immunohematology labs through the propriety benefits of responsive automation. Must meet the volume, turnaround time and efficiency requirements of facility. There is a need for additional samples to be loaded without waiting or delaying the current testing process. The analyzer must be able to minimally perform ABO/Rh Type, Antibody Screening and Identification, Donor Confirmation, and Crossmatch. Additional supplies that must be included are as follows: Two (2) Ortho VISION Tables to support the analyzers Two (2) Drain kits to connect with existing plumbing One (1) printer that is compatible with the Ortho VISION Analyzer is required for printing test results Six (6) Racks per Analyzer, for a total of 12 racks. Sample racks will be specified by the COR upon contract award. Training: Two, one (1) hour training sessions within one (1) week after installation to demonstrate new features on the Ortho VISION Analyzers. One Year Warranty on the Analyzers and supporting equipment. Maintenance and support assistance for the Analyzers must be available 24 hours a day, seven (7) days a week during the term of the contract. A phone number and email address of a support technician must be provided to the COR upon award. Any maintenance, time, and materials needed to maintain the equipment in good working order will be the responsibility of the contractor. The contractor must provide all procedure manuals, troubleshooting manuals, service manuals (as required), and operator manuals. Contractor must provide updates when required. Delivery and Installation- The contractor must provide delivery of two (2) Ortho Clinical Diagnostics VISION Analyzers with Warranty, Sample Racks, drain kits, printer, and two (2) Ortho VISION Tables within 30 days from the contract award date in coordination with the COR to the Lebanon VA Medical Center located at 1700 S. Lincoln Ave., Lebanon, PA 17042; Attn: Warehouse. Equipment Description Product Code Qty ORTHO VISION Analyzer 6904577 2 Warranty & Services Description Equipment Qty Term (Months) ORTHO VISION Maintenance and Support (Basic Care Mon-Sun by noon) 2 60 One Year Warranty All equipment 12 Accessories Description Product Code Qty External Drain Kit (OV) 6904837 2 ORTHO VISION Table 6904701 2 Printer (OV) Lexmark 6986685 1 The contractor must provide all resources necessary to complete installation. Contractor must remove and dispose all waste materials related to installation from the laboratory and facility grounds. Upon Installation, the contractor must perform a successful validation. Validation includes installation, operational, and performance phases. Installation Qualification: Joint validation by the ORTHO onsite technical support specialist and BIOMED. Operational phase: Conducted by ORTHO technical specialist and Blood Bank Lead Technologist to ensure analyzer is operating in the qualifications as specified by ORTHO. Performance Qualification: Contractor must replicate testing performed by the transfusion services, and ensure reliability and consistency of analyzer. Delivery and installation will be within 30 days from the contract award date in coordination with the COR. All coordination for delivery and installation will be provided by the COR. Work Hours: Standard Operational Hours are 0730-1600, Monday thru Friday. If any of the equipment needs moved at any point throughout the period of performance due to laboratory redesign or construction, the contractor must uninstall, move, and reinstall the equipment at no additional cost to LVAMC. Delivery to the facility shall be coordinated at least 72 hours prior to required delivery date with the Warehouse Supervisor. The Warehouse Supervisor has no authority to change the terms and conditions of the awarded contract. Warehouse Supervisor Phone: (717) 272-6621 x4077 The Bio Medical Engineer will need to perform a safety check, Installation Qualifications, and enter the equipment into the system for annual Preventative Maintenance Checks. Placement in the Blood Bank shall be coordinated through the Blood Bank Lead Technologist or Laboratory Manager. The contractor must comply with all applicable installation and facility access policies and procedures, which may be obtained from the COR. The COR has no authority to change the terms and conditions of the awarded contract. Reagents- The testing reagents include ID-MTS Gel Test gel test cards and diluents, and 0.8% Reagent Red Blood Cells for testing on the Lebanon VA owned ORTHO Vision Analyzers. Ortho 3% Reagent Red Blood Cells are used for manual tube testing in the event that the analyzers are inoperative. The Ortho Clinical Diagnostics, Inc. Reagents and Quality Control are used for identifying patient blood types and screening for and identifying antibodies to red cell antigens (Type & Screen); as well as, performing compatibility testing with packed red cell units (Crossmatch). On average, the LVAMC Blood Bank performs 64 Type & Screens, 55 packed red blood cell ABO re-types, and 50 Crossmatches per month. The reagents and quality control must be shipped every 28 days in quantities to meet the monthly testing volume. These reagents and quality control are stable for 28 days. Test reagents and quality control are refrigerated until use and are not used past their expiration date. Ortho-Clinical Diagnostic, Inc. manufactured reagents and quality control (no substitutes) Quantities The items represented in the Schedule of Supplies are based upon previous usage and future projected needs. Delivery Terms Standing order for delivery of reagents and quality control volumes as defined in the Schedule of Supplies. Anticipated delivery date First shipment to begin July 2022 Any deviation from the products listed must be approved by the Contracting Officer and Contracting Officer Representative. Schedule of Supplies Note: Quantities represented below are estimates and have been based upon a 12 month period. IDMTS Reagents Description Product Code Minimum Pkg Qty Price Pkg Annual Value MTS A/B/D Mono & Reverse Grp (5x20) MTS 080515 52 $1,865.29 $96,995.08 MTS A/B/D Group (5x20) MTS 081115 13 $1,888.32 $24,548.16 MTS Anti-IgG-C3D Card (1x20) MTS084014 4 $426.06 $1,704.24 MTS Anti-IgG Card (5x20) MTS 084024 24 $2,027.30 $48,655.20 MTS Buffered Gel Card (5x20) MTS085014 2 $1,941.62 $3,883.24 Traditional Reagents Description Product Code Minimum Volume Price/Pkg Annual Value 0.8% Affirmagen (2x10mL) 719201 156 $34.19 $5,333.64 0.8% Resolve Panel A (1x3mL) 6902317 13 $149.32 $1,941.16 0.8% Resolve Panel B (1x3mL) 6902318 13 $209.05 $2,717.65 0.8% Surgiscreen (3x10mL) 6902316 156 $37.03 $5,776.68 Alba Q Check Z498 104 $125.00 $13,000.00 Consumables Description Product Code Minimum Volume Price Pkg Annual Value MTS Diluent 2 (5x100mL) MTS9230 1 $139.62 $139.62 MTS Diluent 2 Plus (5x100mL) MTS9330 2 $139.62 $279.24 ORTHO 7% BSA (12x5mL) 6844285 64 $57.63 $3,688.32 OV Dilution Trays (16-welltray-180/box) 6904591 1 $180.00 $180.00 OV Evaporation Caps - 10mL (250/box) for reagent red Cells 6843005 4 $62.50 $250.00 VHA SUPPLEMENTAL CONTRACT REQUIREMENTS FOR COMBATTING COVID-19 Contractor employees who work in or travel to VHA locations must comply with the following: Documentation requirements: If fully vaccinated, contractors shall show proof of vaccination. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination. If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor s order or an FDA approved over-the-counter test that includes an affiliated telehealth service. Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel. Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities. For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/19eebca20d1346439b6c3330cac0ddc4/view)
- Record
- SN06318165-F 20220507/220505230101 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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