65--INTENT TO SOLE SOURCE ORTHO CLINICAL GEL CARDS

The Department of Veterans Affairs, VISN 7, intends to award a sole source contract to Ortho-Clinical Diagnostics, Inc., 100 Indigo Creek Drive, Rochester, NY 14626-5101. Ortho Clinical is the proprietary vendor and Control Management, Inc. has exclusive rights to sell gel cards which Ortho-Clinical has the exclusive right to design, install and service Ortho Clinical Vision which is instrumentation owned/leased by the Dorn VA Medical Center. Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals or a solicitation for offers. However, parties interested in responding to this notice shall submit technical data, including cost, sufficient to determine capability in providing the same product to Joseph M. Locke, Contracting Officer at contact@example.gov. Phone number: +1 (555) 000-0000, Ext: 7814 by September 21, 2018 no later than 9am EST. All capability statements received by the closing date of this notification of this synopsis will be considered by the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This acquisition is being conducted under FAR Part 12 commercial procedures. There are no set-aside restrictions for this requirement. The intended procurement will be classified under North American Industry Classification System (NAICS) 424210- In-Vitro Diagnostic Substance. This is for informational purposes only and not to be considered as a commitment by the Government. Any information submitted to this notice of intent is voluntary. STATEMENT OF WORK WJBD VAMC - Pathology and Laboratory Medicine Service Ortho-Clinical Diagnostics, Inc. (Johnson & Johnson) MTSGELCARDS FY19 A. General Information DESCRIPTION OF REQUIREMENT 1. SPECIFICATIONS The Department of Veterans Affairs Medical Center (VAMC), Columbia, South Carolina, hereinafter referred to as the VAMC, has a requirement for These reagents needed to properly test, type and supply blood and blood products throughout the hospital. They must be FDA approved for use. Our physicians rely on these test results in the diagnosis and treatment of our patients. They have come to expect and depend on the high level of service and quality results put out by this laboratory. Disruption of this service will be detrimental to the care of our patients. These Blood Bank Gel cards are to be able to perform ABO identification and/or Antibody Identification for use with VAMC owned two Ortho Clinical Diagnostics Micro Typing Systems ID-MTS Workstations and 2 rental VISION automated instruments. The VISION automated instruments and manual ID-MTS Workstation use gel technology and all products provided must be certified compatible for use with the VA owned MTS equipment and rental automated VISIONS. Products listed in this contract are manufactured by Ortho Clinical Diagnostics. These products have been previously tested and used by the VA Laboratory Blood Bank and have been found to be 100% acceptable for the past 11 years (since 2005). Products required include: MTS Anti-IgG Cards (20/BOX/5=100/CS) MTS Monoclonal and Reverse Group Cards (20/BOX/5=100/CS) MTS A/B/D/A/B/D Monoclonal Grouping Cards. Unit of blood confirmation card. O/A/B/AB Negative blood type (20/BOX/5=100/CS) Anti -A, B (Murine Monoclonal Blend). Unit of blood confirmation card. O Positive blood type (20/BOX/5=100/CS) MTS A/B/A/B/A/B Monoclonal Grouping Cards. Unit of blood confirmation card. A/B Positive blood type (20/BOX/5=100/CS) MTS Anti-C Monoclonal Cards (20/BX) C Phenotyping gel card MTS Anti-c Monoclonal Cards (20/BX) c Phenotyping gel card MTS Anti-E Monoclonal Cards (20/BX) E Phenotyping gel card MTS Anti-e Monoclonal Cards (20/BX) e Phenotyping gel card MTS Buffered Gel Card (5X20)IS XM to rule out ABO incompatibility 2. CONTRACT TYPE AND TERM The VA intends to award a firm-fixed price indefinite delivery indefinite quantity commercial supply contract for the Antibody Identification Reagents listed in the Schedule of Items, limited to the WJBD VA Medical center located in Columbia, SC, at 6439 Garners Ferry Rd, Columbia, SC, 29209. . The contract effective date shall begin on October 1, 2017 and shall be for a base period of one year with four (4) 12-month options to renew. This is a new requirement. APP No. 51421; Base Year Period of performance is 10-1-18 9-30-19. Base Year 10-1-18 9-30-19 Option Year One 10-1-19 9-30-20 Option Year Two 10-1-20 9-30-21 Option Year Three 10-1-21 9-30-22 Option Year Four 10-1-22 9-30-23 The Contractor shall be notified by written notice, within 60 days of the contract anniversary date, of the VAMC s intent to renew. If the option periods are exercised by the VA, the contract will expire on September 30, 2023. The C&A requirements do not apply, therefore a Security Accreditation Package is not required. 3 PRODUCT QUALITY AND QUALITY CONTROL All products offered to the VAMC must be of the same consistent high quality as would be offered to the general commercial public in the United States. (a) All products are purchased subject to acceptance by the VAMC Laboratory Service. Products that fail to meet quality control criteria of the VA Laboratory Service will not be accepted. Products will be rejected and discarded or returned at Contractor s expense if found unsatisfactory by VAMC Laboratory Quality Control when they are received, or later if deterioration of the product occurs before the expiration date. The VAMC will not be financially liable for unacceptable materials. (b) All products must be tested for quality control by the manufacturer, and only those products that pass quality control will be sent to the VAMC. The contractor will demonstrate documentation of quality control performance of any item upon request of the VAMC. (c) Substitution of product may not be made without the approval of the VAMC Laboratory Service and the Contracting Officer or his/her designee. (d) All defective or inferior products must be replaced within 48 hours at no cost to the VA Medical Center. (e) The VA Laboratory is not required to return unacceptable products, but may do so in the rare case where a limited number of items may be returned to solve a quality control problem. (f) It is the vendor s responsibility to provide this medical center with recall notice on any product that has been delivered to this facility that may be defective. Notification shall be made to the Contracting Officer via the most expedient method. 4. CUSTOMER SERVICE A company representative shall visit the V.A. Laboratory no less than once per quarter to review account, provide product information, and answer questions or to handle any problems that may arise, however, monthly visits are preferred. 5. ONE LOT PER DELIVERY The term lot as applies to this contract, is defined as being dispensed from a common reservoir. Reagent/media product must be shipped all in one delivery, and only one lot number per line item per delivery. Multiple deliveries per line item per delivery will not be accepted. The V.A. Laboratory reserves the right to return all products delivered in multiple lot numbers. 6. ROTATION OF STOCK To assure rotation of stock at the distributor, each lot of a product received must have an expiration date the same or later than previously received. ONLY ONE LOT of any item may be shipped per delivery, unless part is the old lot previously received and part is the New lot which will be shipped for the next delivery. ***3 different lots per delivery are never acceptable.*** 7. SHELF LIFE All products must be received in the Laboratory with at least 6 months expiration date. The manufacturer/distributor will provide and update when necessary a shelf life list (time from production to outdate) for each product purchased. 8. CERTIFICATES OF PERFORMANCE Company shall provide certificates of performance for each lot shipped stating compliance with your company s standards, FDA potency requirements, and CLSI standards where they exist. 9. PRODUCT SUBSTITUTION No product substitutions will be accepted without the prior approval of the VA Medical Center Laboratory Service and Contracting Officer. 10. UNINTERRUPTED SOURCE OF SUPPLY By submission of a quotation and acceptance of the contract, the offeror guarantees to provide an uninterrupted source of supply of the established item(s) from which to satisfy the Government's requirement for the performance period of the contract. If however, the contractor anticipates terminating production of an established item(s) and contemplates replacement with alternative item(s), the VA reserves the right to evaluate the potential replacement item(s). There is no guarantee that VA will evaluate any replacement item(s) favorably. If the VA determines the replacement item(s) is unacceptable, that item may be removed from the contract. 11. PLACEMENT OF ORDERS/ORDERING PROCEDURES The Contractor shall provide supplies under this contract only as directed in delivery orders. In accordance with FAR 16.505, each delivery order will include: (i) Date of order (ii) Contract number and order number (iii) Contract item number and description, quantity, and unit price or estimated cost or fee (iv) Delivery or performance date (v) Place of delivery or performance (including consignee) (vi) Packaging, packing, and shipping instructions, if any (vii) Accounting and appropriation data (viii) Method of payment and payment office, if not specified in the contract (ix) Any other pertinent information. Delivery orders for the products will be issued on an as needed basis for a bulk quantity of items. Deliveries for all of the line items will be on a standing order basis. However, supplies for each Delivery Order may be requested either verbally or in writing with the contractor on an on-demand, as needed basis to meet their scheduling needs, up to the bulk delivery order total. Oral or telecommunication requests will be issued only by the Contracting Officer or an authorized Ordering Official located at the VAMC located at 6439 Garners Ferry Rd, Columbia, SC, 29209. (b) The Contracting Officer may issue Delivery Orders under this contract obligating funds for the procurement of specific quantities of reagents prior to the Government needing delivery of said ordered quantities. Delivery Orders may be issued authorizing an Ordering Officer to place orders against the delivery order and schedule specific delivery dates and quantities up to, but not exceeding the total quantity authorized by the Contracting Officer. The following individuals are authorized as Ordering Officers under this contract: Claudia V. Walker, BS, MT (ASCP). Supervisory Medical Technologist Blood Bank, Coagulation and Tissue Bank. Ph: +1 (555) 000-0000 ext. 7371 The contractor will be required to inform the VAMC blood bank ordering officers or contracting officer when the delivery order reaches 80% of the total bulk quantities. Delivery orders to the contractor shall be placed as follows: Vendor s Contact Person: Laura Bryan Contract Manager Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626 Phone: +1 (555) 000-0000 Fax: 585-4533788 12. DELIVERY All supplies shall be delivered FOB Destination to the WJBD VA Medical center located in Columbia, SC, at 6439 Garners Ferry Rd, Columbia, SC, 29209. A Standing Delivery Order will be placed with the requirement for delivery of product every quarter for the: (a) MTS Anti-IgG Cards (20/BOX/5=100/CS) (b) MTS Monoclonal and Reverse Group Cards (20/BOX/5=100/CS) (c) MTS A/B/D/A/B/D Monoclonal Grouping Cards. Unit of blood confirmation card, O/A/B/AB Negative blood type. (20/BOX/5=100/CS) (d) Anti -A,B (Murine Monoclonal Blend). Unit of blood confirmation card. O Positive blood type (20/BOX/5=100/CS) (e) (MTS A/B/A/B/A/B Monoclonal Grouping Cards. Unit of blood confirmation card. A/B Positive blood type (20/BOX/5=100/CS) (f) MTS Anti-C Monoclonal Cards, C Phenotyping gel card (g) MTS Anti-c Monoclonal Cards, c Phenotyping gel card (h) MTS Anti-E Monoclonal Cards, E Phenotyping gel card (i) MTS Anti-e Monoclonal Cards, e Phenotyping gel card (j) MTS Buffered Gel Card IS XM to rule out ABO incompatibility. Products shall arrive at the VAMC on/or about the following dates each year of the contract: October 23, 2016 January 8, 2017 April 9, 2018 July 9, 2019 The VAMC Laboratory may require additional product between scheduled delivery dates and may order products on an on demand/as needed basis. In such cases, delivery will be made within five (5) calendar days after receipt of an order. Deliveries shall be made to: WJBD VA Medical center, Bldg. 100 Warehouse 6439 Garners Ferry Rd Columbia, SC, 29209 . Delivery Times: Between 8:00 a.m. and 3:30 p.m.(Monday-Friday except Federal Holidays) All deliveries shall be accompanied by a delivery ticket or sales slip which shall contain: vendor s name, order number, date of order, date of delivery, itemized list of products furnished including product description and quantity shipped. 13. CHANGES/MODIFICATIONS Changes in the terms and conditions of this contract may be made only by written agreement of the parties. Any and all modifications for changes in: the prices, terms or conditions of this contract, will be prepared for signature by the VA Contracting Officer. 14. RECALLED AND DEFECTIVE PRODUCTS The Contractor will immediately notify the Contracting Officer of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled/defective products at no cost to the Government. The Contractor may be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled/defective products. 15. MSDS, HAZARDOUS MATERIALS and WASTE ANALYSIS The offeror is required to provide a list identifying any "hazardous materials" defined as hazardous under the latest version of Federal Standard No. 313 that may be provided as a part of this contract. Material Safety Data Sheets (MSDS) shall be submitted for all products. Contractor will provide a complete chemical analysis of waste, to include mercury Naazides, carcinogens, reproductive toxins, acute toxins and all other waste that may be considered ignitable, corrosive, reactive or toxic. Contractor will also be required to provide additional subsequent waste analysis studies in the case of any new test or new test formation introductions. Documentation of all analysis will be provided to the VA Contracting Officer for review by the VISN-23 Green Environmental Management Systems (GEMS) Coordinator prior to contract award or introduction of new product after award. 16. INVOICE/PAYMENT The requirements of a proper invoice are as specified in clause 52.212.4. The vendor must reference the order number under which the supplies were ordered on each invoice. Payment to the Contractor will be made by: Billing Address: Tungsten network (formerly OB/O). www.tungsten-network.com/us VA s Electronic Invoice Presentment and Payment System The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge. Promo Code: VAPC17Y18 Buy Code: AAA544240062 Vendor e-Invoice Set-Up Information: Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below: Tungsten e-Invoice Setup Information: +1 (555) 000-0000 Tungsten e-Invoice email: contact@example.gov FSC e-Invoice Contact Information: +1 (555) 000-0000 FSC e-invoice email: contact@example.gov. To improve the timeliness of payments and lower overall administrative costs, the VA strongly encourages contractors to submit invoices using its electronic invoicing system.