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This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in Subpart 12.6, as supplemented with additional information included in this notice. This an... This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The Government reserves the right to make no award from this solicitation.  This is a request for quote (RFQ), and the solicitation number is 36C25024Q0438. The Government anticipates awarding a firm-fixed price Purchase Order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circulars 2024-03, effective 02/23/2024. The associated NAICS Code is 325413, In-Vitro Diagnostic Substance Manufacturing. The Department of Veterans Affairs, Network Contracting Office 10, is soliciting quotes from all sources to supply the Chillicothe VA Medical Center ePlex Reagents. Respondents to this solicitation must fully demonstrate their capability by supplying detailed quote information, along with any other documents necessary to support the requirements below. However, we believe only GenMark Diagnostics, INC. is the only Contractor able to provide this requirement for our existing GenMark ePlex Analyzer.  Quotes are to be provided to Gina P. Crank, Contracting Officer, via email at gina.crank@va.gov, no later than March 20,  2024, by 5:00 PM EST. No telephone calls will be accepted. No submission received after the above-mentioned date and time will be accepted.  STATEMENT OF WORK (SOW) 1. Contract Title. This is a request for proposal for the acquisition of GenMark ePlex Reagents. 2. Background. Procurement of this contract is needed for the purchase of reagents in order to perform COVID testing and Positive Blood Culture Identification on the GenMark ePlex system 3. Scope. The desired reagents must meet the need for detection of Respiratory Viruses including COVID-19 and Positive Blood Culture Identification on the GenMark ePlex analyzer. Specific Tasks. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the Contractor s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible, the necessary consumables in sufficient quantity as required to allow operation of the Contractor s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor. Reagents provided to the under this Agreement will perform in accordance with its Product specifications (per the package insert or user manual. Deliverables. DESCRIPTION ITEM NUMBER QTY/Price ePlex Respiratory Pathogen Panel 2, EUA (12 tests) EA001222 1800 tests 6. Security Requirements The C&A requirements do not apply, and a security accreditation package is not required. 7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). NA 8. Other Pertinent Information or Special Considerations. NA 9. Place of Performance. Chillicothe Veterans Affairs Medical Center 17273 State Route 104 Chillicothe, Ohio 45601 10. Period of Performance 04/01/2024 to 03/31/2025. The 11 Federal Holidays observed by the Federal Government are: New Year s Day January 1 Martin Luther King s Birthday 3rd Monday in January Presidents Day 3rd Monday in February Memorial Day Last Monday in May Juneteenth Day June 19 Independence Day July 4 Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans Day November 11 Thanksgiving Day 4th Thursday in November Christmas Day December 25th The President of the United States of America may declare additional days as a Federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday. PRICE/COST SCHEDULE ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 1,800.00 EA $ $ Genmark Reagents ePlex Respiratory Pathogen Panel 2. Pricing is dependent upon achieving annual test volumes. Funding/Req. Number: 1 538-24-2-775-0060 GRAND TOTAL $ The following solicitation provisions apply to this acquisition: FAR 52.212-1, INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS (JUNE 2020) FAR 52.212-3, OFFERORS REPRESENTATIONS AND CERTIFICATIONS COMMERCIAL ITEMS (FEB 2021) Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, CONTRACT TERMS AND CONDITIONS COMMERCIAL ITEMS (OCT 2018) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The following clauses are incorporated into 52.212-4 as an addendum to this contract: FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) FAR 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016) FAR 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013) VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020) 852.203-70, 852.232-72, 852,233-70, 852.233-71 852.246-71, 852.247-71, 852.270-1 VAAR 852.212-71 GRAY MARKET LANGUAGE (MAY 2016) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Jan 2021 The following subparagraphs of FAR 52.212-5 are applicable: [52.203-6, 52.204-10, 52.209-6, 52.219-6, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.222-50, 52.223-18, 52.225-1, 52.225-13, 52.232-18, 52.232-19, and 52.232-33.] All quoters shall submit the following: A completed schedule with pricing, adequate documentation detailing the capabilities of the product. All quotes shall be sent to the electronically via email to Gina P. Crank @ gina.crank@va.gov. Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. The award will be made to the response most advantageous to the Government. Responses should contain your best terms and conditions. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoters shall list exception(s) and rationale for the exception(s), if any. Submission of your response shall be received not later than March 20, 2024 by 5:00 PM EST to gina.crank@va.gov Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. Point of Contact Gina P. Crank Contracting Officer Network Contract Office (NCO) 10 Office: 614-625-1236 Email: gina.crank@va.gov DEPARTMENT OF VETERANS AFFAIRS Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K) Acquisition Plan Action ID: 36C250-24-AP-2275 Contracting Activity: Department of Veterans Affairs, NCO 10, 2780 Airport Drive, Columbus, OH 43219 for the Chillicothe VA Medical Center, 17273 State Route 104, Chillicothe, Ohio 45601 using 2237 # 538-24-2-775-0060. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: Genmark Reagents ePlex Respiratory Pathogen Panel 2. The desired reagents meet the need for detection of Respiratory Viruses including COVID-19 and on the GenMark ePlex analyzer. Estimated usage is 1800 tests a year. If we cannot perform inhouse testing for COVID-19 procedures will be delayed, isolation costs will increase etc. We would be forced to send all the COVID-19 testing to a reference lab which could take 5-7 days for results. This will give us more capacity for testing. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Chillicothe VA Medical Center previously obtained the GenMark ePlex. This system analyzes RNA using PCR methodology. Testing can be completed in under 2 hours providing clinicians the information required to move forward with treatment. The 65746 SARS-COV-2 PANEL are the only compatible reagents are required to complete the required testing. Description of market research conducted and results or statement why it was not conducted: GenMark is the only distributor of this product. The Chillicothe VA currently owns the GenMark ePlex Analyzer; the requested Reagents are only compatible with the existing GenMark ePlex Analyzer. VIP quired using NAICS 325413 and keyword ePlex with zero SD/VOSB concerns found. The VA Rule of Two can t be obtained. This will be awarded to the OEM GenMark, a Small Business. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. ____________________________ ________________________ Gina P. Crank Date Contracting Officer