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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 36C25022Q0070. 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 2021-07, effective 09/10/2021. 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 Cleveland VA Medical Center ePlex Reagents for patient care. 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 Clinical Micro Sensors, Inc., dba GenMark Diagnostics, Inc. is the only Contractor able to provide this requirement for the GenMark ePlex Analyzer.  Quotes are to be provided to Gina P. Crank, Contracting Officer, via email at gina.crank@va.gov, no later than November 9,  2021, 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): The VA Medical Center (VAMC), Cleveland OH has a requirement for ePlex Respiratory Pathogen Panel 2 for patient care. The Contractor is to provide ePlex Respiratory Pathogen Panel 2 for patient care. DELIVERIES: Deliveries shall be made to: Cleveland Louis Stoke VAMC Wade Park Campus Microbiology Laboratory 10701 East Blvd Cleveland, OH, 44106 1. Background. This task order is required to purchase PCR reagents for COVID on testing methodology currently in use at the Cleveland VA Medical Center. These reagents are proprietary in nature as they are uniquely made for only the Clinical Micro Sensors, Inc. (formerly GenMark) system. These reagents will allow for rapid COVID PCR testing to be done for veterans and employees of the Medical Center. Delivery of supplies will be as requested by the service. 2. Scope. This Purchase Order will enable the rapid testing and diagnoses of COVID positive Veterans and Employees on the GenMark system. This Purchase Order is for use at Louis Stokes Cleveland VA Medical Center only. 3. Specific Tasks. 200 ePlex respiratory pathogen panel 2 kits emergency use authorization. There are 12 tests in one kit. 4. Performance Monitoring Performance will be measured by lot-to-lot parallel testing of each shipment. 5. Security Requirements None. This is a task order for reagent purchase. 6. Place of Performance. Microbiology Laboratory 7. Period of Performance. 11/15/2021 04/14/2022 (can be adjusted depending upon award date). 8. Delivery Schedule. Contractor shall deliver 10 kits per week starting immediately after this Purchase Order is awarded. Kits will need to be shipped until all 200 kits have been delivered. Please ship kits on Mondays so to arrive on Tuesdays. FOB Destination. 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. ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 200.00 KITS eplex Respiratory Pathogens Panel 2, EUA (12 tests) manufacturer part number (mpn): EA001222 Funding/Req. Number: 1 541-22-1-775-0091 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 52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST (DEC 2011) FAR 52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS (APR 2014) FAR 52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON POSTCONSUMER FIBER CONTENT PAPER (MAY 2011) 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.] FAR 52.232-2 SERVICE OF PROTEST (SEPT 2006) - - Hand-Carried Address: Department of Veterans Affairs, Network Contracting Office 10, 2780 Airport Drive, Suite 340, Columbus, OH 43219 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, 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 11/09/2021 5:00 PM Eastern Time 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 and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C250-22-AP-0123 Contracting Activity: Department of Veterans Affairs, VISN 10, Louis Stokes Cleveland VA Medical Center and Network Contracting Office 10, Independence, OH. 2237: 541-22-1-775-0091 Nature and/or Description of the Action Being Processed: This Purchase Order is required to purchase ePlex Reagents for COVID on testing methodology currently in use at the Cleveland VA Medical Center. These reagents are proprietary in nature as they are uniquely made for only the Clinical Micro Sensors, Inc., dba GenMark Diagnostics, Inc. These reagents will allow for rapid COVID PCR testing to be done for Veterans and Employees of the Medical Center. Delivery of supplies will be as requested by the service. This will be awarded as a new FFP Open Market Sole Source Contract. Description of Supplies/Services Required to Meet the Agency s Needs: GenMark manufactures specific reagents and supplies for the GenMark ePlex analyzer currently in use by the Pathology & Laboratory Medicine Service at the Cleveland VA Medical Center to perform COVID-19 viral testing. Pathology & Laboratory Medicine Service requires multiple deliveries of 200 kits @ 10 kits per week starting the week of November 15, 2021 until all 200 kits are shipped (last shipment April 14, 2022. Ship kits on Mondays for a Tuesday arrival. Estimated POP 11/15/2021-04/14/2022. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(1), as implemented by FAR 6.302-1 ( x) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1; ( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3; ( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5; ( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6; ( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7; Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): GenMark is the only source that can provide the specific reagents and supplies for the GenMark ePlex analyzer currently in use by the Pathology & Laboratory Medicine Service at the Northeast Ohio VA Healthcare System to perform COVID-19 viral testing. The reagents are specific to the equipment used and alternate vendors cannot provide acceptable reagent systems. The reagents are only available through GenMark. The vendor was selected based on the availability of the reagents that meet the specific parameters of the equipment (chemical & antibody make-up, configuration, size, shape, etc.). This ensures that the highest standard of accuracy and validation is maintained, as required by the Collage of American Pathologists (CAP) and The Joint Commission (TJC). This presents a compelling need to continue this procurement with the current vendor. Matthew Ohlin, Molecular Account Executive OH & WV, GenMark Diagnostics, Inc. verified by email that The ePlex Respiratory Pathogen Panel 2, EUA is not available through any other distributor or wholesaler. This is a proprietary product that is only available directly from GenMark. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: As stated in section 5 only the GenMark Diagnostics, Inc. Reagents can meet the current needs of the government. There is no NMR Class Waiver and the rule of two cannot be met in any SB socio-economic category. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost will be considered fair and reasonable based on comparison to the IGCE, Published Pricing and prior acquisitions. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The Contracting Officer s Representative conducted market research using the internet search engines and contacting the manufacturer GenMark Diagnostics, Inc. Only GenMark Diagnostics, Inc. was identified as the manufacturer of the technology that can meet the current needs of the government. The Contracting Officer queried VetBiz and DSBS utilizing 325413 and ePlex, both searches returned zero results. GSA, NAC and Google were reviewed which also netted zero results. In addition, as mentioned above, the manufacturer of the requested equipment was contacted; GenMark Diagnostics, Inc. verified that the Manufacturer does not have any authorized resellers or distributors. Any Other Facts Supporting the Use of Other than Full and Open Competition: N/A Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: GenMark Diagnostics, Inc. 5964 La Place Ct Carlsbad, CA, 92008-8829 UNITED STATES DUNS: 962104217 CAGE Code: 6JBA4 Status: Active A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: No actions are being taken to remove or overcome any barriers to competition. Patent laws and licensing agreements limit the influence of the VA on removing barriers to competition at this time. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. _____________________________ Christine Robbins Assistant Laboratory Manager Louis Stokes Cleveland VAMC Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer or Designee s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ Gina P. Crank Contracting Officer NCO 10 One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition. _____________________________ ________________________ Adam P. Weber Date Branch Chief, Supply Team #1 NCO 10