This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. The commercial items procedures of FAR Part 12 will be used. NAICS code is 334516, size standard 500 employees. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-78 effective December 26, 2014. This acquisition is being conducted under the authority of the commercial item test program at FAR 13.5. Only electronic offers will be accepted. Offers are due to [email protected] by 1:00 PM. Pacific Time, February 26th, 2015. CONTRACT ADMINISTRATION DATA 1. Contract Administration: All contract administration matters will be handled by the following individuals: a. CONTRACTOR: b. GOVERNMENT: Contracting Officer 00261 Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System 150 Muir Road Martinez CA 94553-4668 2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with: [X] 52.232-34, Payment by Electronic Funds Transfer-Other Than System For Award Management, or [] 52.232-36, Payment by Third Party 3. INVOICES: Invoices shall be submitted in arrears: a. Quarterly [] b. Semi-Annually [] c. Other [X] Upon Government acceptance 4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. Department of Veterans Affairs FMS-VA-2(101) Financial Services Center PO Box 149971 Austin, TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows: AMENDMENT NO DATE STATEMENT OF WORK HIV-1 GENOTYPING TEST (Reagent/Instrument Rental) PART A - GENERAL INFORMATION A.1. INTRODUCTION: This requirement is for HIV-1 Genotyping test kits and supporting reagents and supplies. Instruments to perform testing are also included in the price of the test kits. Instruments and reagent test kits are required to be in place by April 2015. Old method has been discontinued production by the manufacturer, therefore needing an immediate replacement to continue patient sample testing. A.2. BACKGROUND: HIV-1 Genotyping System is used in detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs, as an aid in monitoring and treating HIV infection. The indications for use encompass on HIV-1 infected individuals at drug therapy failure (with increased viral load) before therapy switch and/or HIV-1 infected individuals at initial presentation, before initial drug therapy. A.3. SCOPE OF WORK: The scope of testing includes performing viral DNA/RNA isolation from patient samples and automated molecular capillary sequencing molecular based testing on specialized equipment. Viral DNA/RNA is tested under exacting conditions. Testing is performed for VA Palo Alto and for other VA hospitals in VISN 21 and outside the VISN. This includes: Northern California System of Clinics Fresno VAMC Honolulu VAMC Reno VAMC Durham, NC VAMC Phoenix, AZ VAMC PART B - WORK REQUIREMENTS B.1. TECHNICAL REQUIREMENTS / SALIENT CHARACTERISTICS: The following criteria / salient characteristics are required to provide instruments, reagents, supplies, and a maintenance contract for HIV-1 Genotype Testing for VISN 21 and outside the VISN, performed at the VA Palo Alto Health Care System: (a) The estimated (annual) quantity of HIV-1 Genotyping tests per year is 120. (b) The HIV-1 Genotyping Kit shall be capable of detecting drug resistance mutations present in plasma HIV-1 virus in the entire protease and most of the reverse transcriptase regions of HIV-1 genome. (c) The HIV-1 Genotyping test shall be FDA approved. In addition it shall have the capability to be used in an open-mode platform to use for Laboratory Developed Tests. (d) The test shall be able to detect HIV-1 resistance in plasma samples with a viral load of 2,000 copies/ml or less. The system shall also detect primary and secondary mutations, insertions, deletions and be able to generate a HIV resistance report for sequences which contain these elements. (e) The following Reagents and Consumables shall be included (brand name or equal): " ViroSeq HIV-1 Genotyping System v2.0, with ViroSeq HIV-1 Sample Preparation Module, ViroSeq HIV-1 RT-PCR Module, ViroSeq HIV-1 Sequencing Module, ViroSeq HIV-1 8E5 Control Module. " Coded Panel for initial certification " PCR Cleanup Kit " Sequencing Consumables Kit (f) Software ViroSeq HIV-1 Genotyping System Software v2.8 or any new updates in equipment or software. (g) The following instrumentation shall be required: Applied Biosystems 3130xl/3130 Genetic Analyzer with: o Data Collection software v.3.0 o Firmware version 6286200-02 or 6286250-02 PC computer with: o Microsoft WindowsXP Professional edition, Service Pack 2 o Intel Pentium 4 processor,2 GHz o 1 GBRAM o Dual 36 GB hard drives (h) Sequencer Instrument shall have an autoloading of samples feature in order to provide walkaway processing. (i) The instrument/software shall have a capability to set up computer data interface connections between the Data Analysis PC computer and to VISTA for data transmissions. (j) The specific qualifications of the contractor shall include capability providing all reagents and supplies in a timely manner and in lot sizes large enough to allow 6 - 12 months stability. (k) Validation studies shall show 100% correlation from previous patient results as obtained from Siemens Trugene method. (l) Upon completing an acceptable evaluation/validation of the instrument, the Period of Performance on the contract is for one (1) base year plus four (4) one-year options. (m) The method of referral, records management procedures, scheduling, and/or documentation procedures shall be done through 2237s for reagents. The instrumentation cost and maintenance is part of the reagent rental contract. Quarterly evaluations of manufacturer will be assessed. (n) Quality Assurance/utilization review procedures shall include vendor/method review and bi-annual reporting at the laboratory QI meeting and quarterly assessment reports by the COTR. (o) Testing with the instruments, reagents, and supplies shall be performed at VA Palo Alto Health Care System in Pathology and Laboratory Medicine Service. (p) The contract monitoring and record keeping procedures shall be performed through quarterly assessment by the COTR or designated VA Point of Contact (POC). (q) The laboratory shall provide supply orders per agreement, meet expected volumes, pay invoices on time. The company must provide reagents and supplies in a timely manner without backorders that affects laboratory operations at VA Palo Alto. The supplier shall provide maintenance in a timely manner so that turnaround times can be met for VISN 21 testing services. (r) Both parties shall have an equal understanding of the services to be provided by the Contractor include the Technical Help Phone Line and the Technical Field Service shall be able to respond in a timely manner: the Technical Phone Help Line shall respond within one hour of the call. The Technical Field Service shall respond and send out a Field Service Technician within 24 hours of the call for help. B.2. DELIVERABLE ITEMS: Orders shall be placed as needed by the Molecular Pathology Supervisor; Pathology & Lab Medicine Service, Delivery would be to: VA Palo Alto HCS Warehouse Building 50. Attn: Molecular Path Lab B100-E4-382, 3801 Miranda Ave, Palo Alto CA.94304. Final delivery location of all reagents will be to Building100 E4-382. Invoices are to be submitted to the VA Austin FSC, Austin TX. Instruments: Associated instruments and equipment, computers, data management systems to perform HIV-1 Genotype testing will be placed in the VA Palo Alto HCS Molecular Pathology Laboratory (Bldg 100-F4-173) B.3. EQUIPMENT, MAINTENANCE & SERVICE: This contract should be structured as a cost per test or a reagent rental contract. Maintenance and repairs are included in pricing. Once a need for repair is identified, it is expected the service representative shall arrive within 24 hours. A maintenance schedule shall be set and followed by the manufacturer. Documentation of all visits shall be provided to the Molecular Pathology supervisor. The vendor shall agree to upgrade equipment to newer models within 90 days after they are made commercially available. TRAINING: Operators' Training shall be provided and all expenses for off-site training will be paid for by vendor as part of purchase contract. B.4. COMPLIANCE: Vendor compliance shall be measured by ability to deliver supplies by the date required, quality of test kits and reliability of test systems. Quarterly documentation will be provided in the COR file. Price/Cost Schedule Item Information. THIS IS A BRAND NAME OR EQUAL COMBINED SYNOPSIS / SOLICITATION. PREFERRD BRAND NAME IS ABBOTT MOLECULAR. BASE YEAR - 3/1/2015 to 2/29/2016 CLIN DESCRIPTION Brand name Abbott Molecular or Equal Estimated Quantity Unit Price Extended Price 0001 VS HIV-1 v2 GT Kit, IVD, 48 tests per kit, Abbott Molecular # 04J94-091 or equal 4 $ $ 0002 Seq Consumables Pack, 96 tests per kit, Abbott Molecular # 04J94-092 or equal 2 $ $ 0003 PCR Cleanup Kit 96 tests per kit, Abbott Molecular # 04J94-073 2 $ $ 0004 Instrument ABI 3130 for Genotype Sequencing, to perform above tests, Abbott Molecular # 7N74-001 1 $ $ Base Year Total: $ OPTION YEAR 1 - 3/1/2016 to 2/29/2017 CLIN DESCRIPTION Brand name Abbott Molecular or Equal Estimated Quantity Unit Price Extended Price 0005 VS HIV-1 v2 GT Kit, IVD, 48 tests per kit, Abbott Molecular # 04J94-091 or equal 4 $ $ 0006 Seq Consumables Pack, 96 tests per kit, Abbott Molecular # 04J94-092 or equal 2 $ $ 0007 PCR Cleanup Kit 96 tests per kit, Abbott Molecular # 04J94-073 2 $ $ 0008 Instrument ABI 3130 for Genotype Sequencing, to perform above tests, Abbott Molecular # 7N74-001 1 $ $ Option Year 1 Total: $ OPTION YEAR 2 - 3/1/2017 to 2/29/2018 CLIN DESCRIPTION Brand name Abbott Molecular or Equal Estimated Quantity Unit Price Extended Price 0009 VS HIV-1 v2 GT Kit, IVD, 48 tests per kit, Abbott Molecular # 04J94-091 or equal 4 $ $ 0010 Seq Consumables Pack, 96 tests per kit, Abbott Molecular # 04J94-092 or equal 2 $ $ 0011 PCR Cleanup Kit 96 tests per kit, Abbott Molecular # 04J94-073 2 $ $ 0012 Instrument ABI 3130 for Genotype Sequencing, to perform above tests, Abbott Molecular # 7N74-001 1 $ $ Option Year 2 Total: $ OPTION YEAR 3 - 3/1/2018 to 2/29/2019 CLIN DESCRIPTION Brand name Abbott Molecular or Equal Estimated Quantity Unit Price Extended Price 0013 VS HIV-1 v2 GT Kit, IVD, 48 tests per kit, Abbott Molecular # 04J94-091 or equal 4 $ $ 0014 Seq Consumables Pack, 96 tests per kit, Abbott Molecular # 04J94-092 or equal 2 $ $ 0015 PCR Cleanup Kit 96 tests per kit, Abbott Molecular # 04J94-073 2 $ $ 0016 Instrument ABI 3130 for Genotype Sequencing, to perform above tests, Abbott Molecular # 7N74-001 1 $ $ Option Year 3 Total: $ OPTION YEAR 4 - 3/1/2019 to 2/29/2020 CLIN DESCRIPTION Brand name Abbott Molecular or Equal Estimated Quantity Unit Price Extended Price 0017 VS HIV-1 v2 GT Kit, IVD, 48 tests per kit, Abbott Molecular # 04J94-091 or equal 4 $ $ 0018 Seq Consumables Pack, 96 tests per kit, Abbott Molecular # 04J94-092 or equal 2 $ $ 0019 PCR Cleanup Kit 96 tests per kit, Abbott Molecular # 04J94-073 2 $ $ 0020 Instrument ABI 3130 for Genotype Sequencing, to perform above tests, Abbott Molecular # 7N74-001 1 $ $ Option Year 4 Total: $ GRAND TOTAL (base + all option years): $ Delivery Schedule ITEM NUMBER DELIVERY DATE All items SHIP TO: VA Palo Alto Health Care System Pathology & Laboratory Medicine Service 3801 Miranda Avenue Palo Alto, CA 94304-1290 STATED QUANTITIES ARE ESTIMATES ONLY AND SHALL ONLY BE DELIVERED ON AN "AS NEEDED" BASIS WHEN REQUESTED BY AUTHORIZED VA PERSONNEL. BASE YEAR - 4/1/15 - 3/31/16 OPTION YEAR 1 - 4/1/16 - 3/31/17 OPTION YEAR 2 - 4/1/17 - 3/31/18 OPTION YEAR 3 - 4/1/18 - 3/31/19 OPTION YEAR 4 - 4/1/19 - 3/31/20 SOLICITATION PROVISIONS and CONTRACT CLAUSES: Clauses " FAR 52.252-2 - Clauses Incorporated by Reference (Feb 1998) For the purposes of this clause, the fill-in's are http://www.acquisition.gov/far/index.html and http://www.va.gov/oal/library/vaar/ respectively. " FAR 52.212-4 Contract Terms and Conditions -- Commercial Items (Dec 2014) " FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items (Dec 2014) For the purposes of this clause, items (b) 1, 4, 8, 12, 16, 22, 26, 27, 28, 29, 30, 31, 32, 39, 40, 41, 43, and 50 are considered checked and applicable. " FAR 52.216-1 Type of Contract (April 1984) For the purposes of this clause, the fill-in is "Firm Fixed Price." " FAR 52.217-8 Option to Extend Services (Nov 1999) For the purposes of this clause, the fill-in is "30 days." " FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000) For the purposes of this clause, the fill-in's are"30 days," "15 days," and "five (5) years," respectively, in this order. " FAR 52.232-38 Submission of Electronic Funds Transfer Information with Offer (July 2013) " VAAR 852.203-70 Commercial Advertising (Jan 2008) " VAAR 852.211-70 Service Data Manuals (Nov 1984) " VAAR 852.211-73 Brand Name or Equal (Jan 2008) " VAAR 852.246-71 Inspection (Jan 2008) " VAAR 852.232-72 Electronic Submission of Payment Requests (Nov 2012) " VAAR 852.246-70 Guarantee (Jan 2008) For the purposes of this clause, the fill-in is "one year". Provisions " FAR 52.252-1 - Solicitation Provisions Incorporated by Reference (Feb 1998) For the purposes of this provision, the fill-in's are http://www.acquisition.gov/far/index.html and http://www.va.gov/oal/library/vaar/ respectively. " FAR 52.211-6 Brand Name or Equal (Aug 1999) " FAR 52.212-1 Instructions to Offerors - Commercial Items (April 2014) " FAR 52.212-3 Offeror Representations and Certifications -- Commercial Items (Dec 2014) " FAR 52.217-5 Evaluation of Options (July 1990) " VAAR 852.233-70 Protest Content/Alternative Dispute Resolution (Jan 2008) " VAAR 852.233-71 Alternative Protest Procedure (Jan 1998) 52.212-2 EVALUATION - COMMERCIAL ITEMS (OCT 2014) The Government shall evaluate proposals based on the lowest priced, responsible, technically acceptable offer. The following shall be used to evaluate offers: Technical Capability. Offeror's technical capability shall be evaluated based on the information clearly provided in their quote in response to the salient characteristics stated under B.4 Price/Cost Schedule. This is a brand name or equal solicitation. "Or equal" items shall meet all salient characteristics. Offerors must clearly and concisely state how their product meets the salient characteristics. A Note on Determining Responsibility of Suppliers: All relevant facts and circumstances gathered from sources of information available to the Government (e.g., National Institutes of Health [NIH] Contractor Performance System [CPS] and Past Performance Information Retrieval System [PPIRS]) will be used as part of determining the responsibility of prospective suppliers. If an Offeror has not commented on negative past performance evaluations obtained by the Technical Evaluation Board, the Offeror may be given the opportunity to explain and/or mitigate adverse past performance during verbal or written interactions after receipt of proposals. Offerors who do not have relevant past performance will receive a neutral rating (neither favorable nor unfavorable).

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