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36C24419Q1165 Page 1 of Page 2 of 47 Page 1 of Solicitation Number / RFQ 36C24419Q1165 - Brain Natriuretic Peptide (BNP) reagents This is a combined synopsis/solicitation for commercial items prepared... 36C24419Q1165 Page 1 of Page 2 of 47 Page 1 of Solicitation Number / RFQ 36C24419Q1165 - Brain Natriuretic Peptide (BNP) reagents This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, 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. This is a Request for Quote (RFQ). The government anticipates awarding a firm-fixed price contract resulting from this solicitation. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2019-06 9/10/2019. The North American Industrial Classification System (NAICS) code for this procurement is 325413 with a small business size standard of 1,250 employees. This solicitation is issued as an unrestricted procurement. The Corporal Michael J. Crescenz Department of Veterans Affairs (CMCVAMC), Regional Procurement Office East, Network Contracting Office 4 (NCO 4), in Philadelphia, Pennsylvania is soliciting offers from authorized distributors to provide Quidel BNP reagents to run on the existing Beckman Coulter Immunochemistry DX1800 Analyzer. The BNP reagent is used by Physicians to diagnose Congestive Heart Disease (CHD), make treatment decisions and monitor patients. The Quidel BNP reagents are the only regents that can be utilized on the Beckman Coulter Analyzer which are used by the Pathology and Laboratory Medicine Department. No other types of substitute or third-party reagents will fit the need of the CMC VAMC for the reasons noted. The Quidel BNP test is the only BNP test approved by the FDA that will run on the Beckman Coulter Immunochemistry Analyzer. One award will be issued for a base year of one year with two, one-year option periods. Contracting Office Address: Department of Veterans Affairs Regional Procurement Office East Network Contracting Office 4 (NCO 4) 100 S. Independence Mall West 5th Floor Philadelphia, PA 19106 Place of Performance: Corporal Michael J. Crescenz Veterans Affairs Medical Center 3900 Woodland Avenue Philadelphia, PA 19104 Attn: Rosemary Millili, Chemistry Supervisor Room 3B134 Quotes shall be sent to the Contracting Officer by 11:00 AM EST, Tuesday, September 17, 2019. They shall be submitted to Maureen.Jordan@va.gov. All submission shall be 5MB or less. If the email is more than 5MB, then please submit in multiple emails labeling 1 of XX, 2 of XX, etc. 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 Contracting Officer by Friday, September 13, 2019 at 4:00 PM. Period of Performance: The period of performance will start on October 1, 2019. The base year is one year and will end September 30, 2020. If exercised, the first option period/year will extend the contract period of performance from October 1, 2020 through September 30, 2021. If exercised, the second option period/year will extend the contract period of performance from October 1, 2021 through September 30, 2022. Base Year - Estimated Annual Quantity CLIN Description Quantity Unit Unit Price Amount 0001 BNP Test for Beckman Coulter Immunoassay Systems (100 tests/box ITEM #98200) Box 100 0002 BNP Control Kit (ITEM # 98201) Each 8 0003 BNP Calibration/Verification Test (ITEM #98202) Box 24 BASE YEAR TOTAL COST $________________ Option Year One - Estimated Annual Quantity CLIN Description Quantity Unit Unit Price Amount 1001 BNP Test for Beckman Coulter Immunoassay Systems (100 tests/box ITEM #98200) Box 100 1002 BNP Control Kit (ITEM # 98201) Each 8 1003 BNP Calibration/Verification Test (ITEM #98202) Box 24 OPTION YEAR ONE TOTAL COST $______________ Option Year Two - Estimated Annual Quantity CLIN Description Quantity Unit Unit Price Amount 2001 BNP Test for Beckman Coulter Immunoassay Systems (100 tests/box ITEM #98200) Box 100 2002 BNP Control Kit (ITEM # 98201) Each 8 2003 BNP Calibration/Verification Test (ITEM #98202) Box 24 OPTION YEAR TWO TOTAL COST $_______________ STATEMENT OF WORK A. SCOPE OF PROCUREMENT Pathology and Laboratory Medicine Service (P&LMS), Chemistry section is looking to purchase reagents that are compatible with the existing immunoassay platform which is the Beckman Coulter DXI800 Analyzer for Brain Natriuretic Peptide (BNP). The DXI800 is the instrument that is used in Chemistry for Immunoassay testing. This test is needed to help diagnose and manage Congestive heart failure in the VA patient population at the CMC VAMC. Only reagents made strictly for the Beckman Coulter DXI800 analyzer is acceptable. B. DEFINITIONS BNP = brain natriuretic peptide C. GENERAL REQUIREMENTS FOR REAGENT The below requirements for BNP reagent, calibrators and QC material are needed to test for BNP for to help clinicians diagnose and manage congestive heart failure in patient at the CMCVAMC. The lot number changes need to be minimized and managed by the CMCVAMC lab due to expiration dates of the reagent/calibrators and QC material. Each lot has a series of parameters that need to be fulfilled to maintain College of American Pathology Accreditation. Technical Requirements 1. Reagent must be formulated to be tested on the existing platform of immunoassay analyzers the Beckman Coulter DXI800. The reagent needed is BNP Brain Natriuretic Peptide. It must be packaged in cartridges of 50 with 100 tests in a box of reagent. 2. Corresponding Calibrators (6 point calibrators) are needed to calibrate the reagent on the DXI800 analyzer. 3. Corresponding Quality Control (QC) is needed to ensure that the reagent and calibration are performing as expected and accurate results are produced. 4. Once opened, the reagent must be able to be stable on the instrument for a period of 28 days. 5. Using this reagent, the sample required for testing must be EDTA plasma. 6. Unit of measure must be pg/ml. 7. Analytical Measurement Range for this test must be 0 5000 pg/ml. 8. Must have the ability to dilute specimens for a higher result if necessary. Instrument should allow for precision on specimens diluted at a 1:20 ratio extending the reportable range to 100,000 pg/ml. 9. Must also be able to purchase calibrators and quality control material that can be used with this reagent. The calibrators should be 6 levels and the quality control material should be 3 levels. Calibrator values and Quality Control values must cover the entire analytical range. 10. Substances such as Hemoglobin, triglycerides, bilirubin, fibrinogen and human serum albumin must not be interfering substances that would affect the testing. 11. Within run precision must be within 3.1% CV. 12. 50 Test/Kit, Packaged 2 Kits/Box. 13. Sensitivity 80.6%. 14. Reagents will be shipped within 2 business days from ordering date. 15. Technical Support is provided as needed. Packaging and Inspection All materials will be packaged to ensure safe handling. If an item is delivered and, upon inspection, is found to be unacceptable, the contractor shall deliver a replacement item with in two business days at no additional cost to the Government. Quality If reagent material fails to perform to acceptable standards, as determine by the government, the failure will be reported to the contractor and the contractor shall send replacement items at no additional charge within one business day. Invoicing Payments shall be made 30 days in arrears upon receipt of a proper invoice. All invoices shall be submitted online. VA s Electronic Invoice Presentment and Payment System The FSC uses a third-party contractor, OB-10, to transition vendors from paper to electronic invoice submission. Please go to this website: http://ob10.com/us/en/veterans-affairs-us/ to begin submitting electronic invoices, free of charge. All orders placed against this Contract shall be by authorized individuals within the scope of their authority as designated by the facility participating in this agreement. Unless otherwise agreed to, all deliveries must be accompanied by delivery tickets or sales slips that contain the following information as a minimum: Contractor Name Date of purchase Date of shipment Description of each item, including (when applicable) model number Quantity for each item in the order Unit price and extended (quantity x unit price) price for each item. END OF STATEMENT OF WORK This solicitation requires registration with the System for Award Management (SAM) prior to award, pursuant to applicable regulations and guidelines. Registration information is at www.sam.gov. Confirmation of SAM registration will be validated prior to awarding a contract. This is an open-market combined synopsis/solicitation for commodities as defined herein. The government anticipates awarding one firm-fixed price contract as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. 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). Evaluation of Quotes - The Government anticipates awarding one firm-fixed price contract from this solicitation. Evaluations will be conducted to determine best value in accordance with FAR 13.106-2(b)(3). For the purposes of evaluating competing quotes, Quoters should submit quotes that include the following documentation: Technical Capability and Documentation: Technical Capability Provide a narrative statement specifically detailing the Quoters ability to provide the Quidel BNP reagents needed for the Beckman Coulter DX1800 Analyzer. The supplies shall meet the requirements (as well as delivery) in the Statement of Work. The Government will award a contract resulting from this solicitation to the responsible Quoter that represents the best benefit to the Government at a price that can be determined reasonable. The Government will evaluate price, technical capability, and past performance. The Government will perform a comparative evaluation of the product quoted. The Government will compare quotes to one another to select the product that best benefits the Government by fulfilling the requirement. The Contracting Officer will award one firm fixed price contract resulting from this RFQ to the responsible Quoter whose quote conforming to the RFQ is most advantageous to the Government. The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Items (Oct 2018) FAR 52.212-3, Offerors Representations and Certifications Commercial Items (Oct 2018) FAR 52.233-2, Service of Protest (Sep 2006) FAR 52.204-7 System for Award Management (Oct 2018) VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors (Jul 2016) (Deviation) VAAR 852.233-70, Protest Content/Alternative Dispute Resolution (Oct 2018) VAAR 852.233-71, Alternate Protest Procedure (Oct 2018) FAR 52.233-2 Service of Protest (Sep 2006) Protests, as defined in section 33.101 of the Federal Acquisition Regulation, that are filed directly with an agency, and copies of any protests that are filed with the Government Accountability Office (GAO), shall be served on the Contracting Officer (addressed as follows) by obtaining written and dated acknowledgment of receipt from: Hand-Carried Address: Regional Procurement Office East, Network Contracting Office 4 (NCO 4) Department of Veterans Affairs 100 S. Independence Mall West 5th Floor Philadelphia, PA 19106 Mailing Address: Regional Procurement Office East, Network Contracting Office 4 (NCO 4) Department of Veterans Affairs 100 S. Independence Mall West 5th Floor Philadelphia, PA 19106 (b) The copy of any protest shall be received in the office designated above within one day of filing a protest with the GAO. (End of Provision) Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov 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) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders (May 2019) The following subparagraphs of FAR 52.212-5 are applicable: Subparagraph (b)(1), (b)(4), (b)(8), (b)(16), (b)(22), (b)(26), (b)(27), (b)(28), (b)(29), (b)(30),(b)(31), (b)(32), (b)(33), (b)(42), (b)(48), (b)(49), (b)(55). FAR 52.232-19, Availability of Funds for the Next Fiscal Year (Apr 1984) VAAR 852.203-70, Commercial Advertising (May 2018) VAAR 852.215-71, Evaluation Factor Commitments (Dec 2009) VAAR 852.232-72, Electronic Submission of Payment Requests (Nov 2018) FAR 52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform Employees of Whistleblower Rights (Apr 2014) VAAR 852.246-71 Rejected Goods (Oct 2018) 52.217-9 Option to Extend the Term of the Contract (Mar 2000) (a) The Government may extend the term of this contract by written notice to the Contractor within 15 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed three years. (End of Clause)