Automated Molecular Instruments for the Qualitative Detection of SARS-CoV-2

Request For Quote (RFQ) 70Z02321QP1733500 Automated Molecular Instruments for the Qualitative Detection of SARS-CoV-2 Issued by: Department of Homeland Security (DHS) United States Coast Guard Office of Contract Operations 1430A Kristina Way Chesapeake, VA 23326 Due Date/Time: September 23, 2021 at 12:00 PM ET NOTICE FOR FILING AGENCY PROTESTS United States Coast Guard Ombudsman Program It is the policy of the United States Coast Guard (USCG) to issue solicitations and make contract awards in a fair and timely manner. The Ombudsman Program for Agency Protests (OPAP) was established to investigate agency protest issues and resolve them without expensive and time-consuming litigation. OPAP is an independent reviewing authority that is empowered to grant a prevailing protester essentially the same relief as the Government Accountability Office (GAO). Interested parties are encouraged to seek resolution of their concerns within the USCG as an Alternative Dispute Resolution (ADR) forum rather than filing a protest with the GAO or some external forum. Interested parties may seek resolution of their concerns informally or opt to file a formal agency protest with the Contracting Officer or Ombudsman. Informal Forum with the Ombudsman. Interested parties who believe a specific USCG procurement is unfair or otherwise defective should first direct their concerns to the applicable Contracting Officer. If the Contracting Officer is unable to satisfy their concerns, interested parties are encouraged to contact the U.S. Coast Guard Ombudsman for Agency Protests. Under this informal process the agency is not required to suspend contract award performance. Use of an informal forum does not suspend any time requirement for filing a protest with the agency or other forum. In order to ensure a timely response, interested parties should provide the following information to the Ombudsman: solicitation/contract number, contracting office, Contracting Officer, and solicitation closing date (if applicable). Formal Agency Protest with the Ombudsman. Prior to submitting a formal agency protest, protesters must first use their best efforts to resolve their concerns with the Contracting Officer through open and frank discussions. If the protester's concerns are unresolved, an Independent Review is available by the Ombudsman. The protester may file a formal agency protest to either the Contracting Officer or as an alternative to that, the Ombudsman under the OPAP program. Contract award or performance will be suspended during the protest period unless contract award or performance is justified, in writing for urgent and compelling reasons or is determined in writing to be in the best interest of the Government. The agency's goal is to resolve protests in less than 35 calendar days from the date of filing. Protests shall include the information set forth in FAR 33.103(d) (2). If the protester fails to submit the required information, resolution of the protest may be delayed or the protest may be dismissed. To be timely protests must be filed within the period specified in FAR 33.103(e). Formal protests filed under the OPAP program should be submitted electronically to OPAP@uscg.mil and the Contracting Officer of by hand delivery to the Contracting Officer. Election of Forum. After an interested party protests a Coast Guard procurement to the Contracting Officer or the Ombudsman, and while the protest is pending, the protester agrees not to file a protest with the GAO or other external forum. If the protest is filed with an external forum, the agency protest will be dismissed. The Ombudsman Hotline telephone number is (202) 372-3695. (End of notice) Combined Synopsis and Solicitation Notice Information A. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 and FAR 13, 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 acquisition is being conducted as unrestricted for commercial items prepared in accordance with FAR Part 12. FAR Part 13.5, Simplified Procedures Certain Commercial Items, will be followed for this requirement. B. Solicitation number is 70Z02321Q1733500 and is being issued as a Request for Quote (RFQ). C. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (2021-07, effective 10 September 2021). See http://farsite.hill.af.mil/vffara.htm for this information. D. The associated NAICS code is 334516 and this procurement: is not being set-aside for small businesses. is being set-aside for small businesses. The small business size standard is 1,000 employees. E. The United Stated Coast Guard (USCG), Office of Health, Safety and Work Life (CG-HSWL) Center has a requirement to obtain clinical laboratory instrumentation for ongoing COVID-19 pandemic testing needs for organic health care within the USCG. Described in Attachment 1 - Technical Requirements. F. The Government intends to award a single Firm-Fixed-Priced (FFP) purchase order. G. Place of Delivery: See Attachment 1 - Technical Requirements H. The provision at FAR 52.212-1, Instructions to Offerors - Commercial Items (DEVIATION 2018-0018)(Oct 2018) applies to this acquisition. I. Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer. J. Clause 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. K. Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and is provided as Attachment 2 - FAR 52.212-5 herein. L. Questions All questions shall be submitted via email to the USCG Contract Specialist, Karen Marshall (Karen.M.Marshall@uscg.mil), and to the USCG Contracting Officer, Heather Weaver (Heather.A.Weaver@uscg.mil. The USCG will accept questions only in an email format and will disregard questions received in any other format. M. List of Attachments Attachment 1 - Technical Requirements Attachment 2 - FAR 52.215-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items Attachment 3 - Pricing Schedule N. Quote Submission Quotes must respond to all requirements of the solicitation and not alter or rearrange the solicitation. Vendors are advised the Government may incorporate any portions of the quote into the resulting award. In presenting material in the quote, vendors are advised that quality of information is more important than quantity. Clarity, brevity, and logical organization shall be emphasized during quote preparation. Statements made in the quote that do not have supporting information may be considered inadequate by the Government and may result in assessing weaknesses or deficiencies. Qoutes must include any data that illustrates the adequacy of the various assumptions, approaches, and solutions to problems. Failure to address a specific factor clearly may be considered a deficiency. Unnecessarily elaborate brochures or other presentation materials beyond that sufficient to present a complete and effective quote is neither necessary nor desired. The Government advises that taking exception to or deviating from any term or condition of the RFQ may result in the assessment of a deficiency to the quote. The Government will post all amendments to this solicitation at https://www.sam.gov. Quotes shall include an acknowledgment of all amendments to the solicitation. Submit Offers via e-mail to the following: E-Mail to karen.m.marshall@uscg.mil (if e-mail attachments are under 10MB) Note: Attachments to e-mails must be less than 10MB and USCG policy does not allow receipt of WinZip files via e-mail. All quotes, all email, and all attachments shall be clearly marked with the RFQ number. Responses to this RFQ must be received no later than September 23, 2021 at 12:00 pm ET. The Government will proceed with evaluations and conduct any exchanges (if necessary) based on the written quotes. The Government intends to evaluate quotes and award without communications or exchanges with Offerors. The Offerors should therefore propose their best approach to meeting the requirements of the solicitation. However, the Government reserves the right to enter into communications or exchanges with Offerors if it is deemed to be in the best interests of the Government. Quote Format Written quotes must be formatted using Times New Roman 12 pt, singled spaced with 1-inch margins on all four sides, and formatted for standard 8.5 x 11 paper. All pages shall include a header containing: the RFQ number; the Company name; and Volume Title. All pages shall be numbered in the lower right hand corner in a manner that identifies the volume and page number. Do not use foldout pages. Quote Content The Offeror's quote and in the information contained within shall be presented in a clear and concise, fashion, with sequential page numberings in the footer of each document and a logical structure throughout. The due date is for receipt of the quote in its entirety no later than Thursday, September 23, 2021, at 12:00 PM ET. Quoter's shall submit a signed and dated quote on company letterhead/stationery that contains, at a minimum, the following sections and information: Cover /Letter shall include the following at a minimum: Request for Quote (RFQ) number Name, Address, Telephone Number, and DUNS Number of the company Name, Title, Phone Number, and E-mail Address of an Authorized Official of the company If applicable, subcontractor name(s) and DUNS number(s) Business size classification, e.g., large/small business, 8(a) business, etc. A statement specifying the extent of agreement with all terms, conditions, and provisions included in this Solicitation. Acknowledgment of Solicitation Amendments A completed copy of the representations and certifications at FAR 52.212-3 ALT 1 (see FAR 52.212-3(b)(OCT 2018) for those representations and certifications that shall be completed electronically). Any representations and certifications not presently included in the System for Award Management (SAM) or SAM.gov must be included A statement specifying the extent of agreement with all terms, conditions and provisions included in the solicitations. Quotes that fail to include required information or representations, or reject the terms and conditions of the solicitation may be excluded from consideration. Technical Capability shall demonstrate at a minimum that the proposed item meets or exceed the technical characteristics detailed below: Provides SARS-CoV-2 testing capability Instrument is CLIA waived Instrument provides laboratory RT-PCR results (low detection limit) and results do not need to be sent for confirmation (No confirmation required for negative results) and no presumptive negative results Instrument size and dimensions are compact and portable due to limited space in clinics and cutters Single instrument has a throughput of: ? 4 tests at one time; Walkaway testing. Test kits can be stored at a wide temperature range and does not require refrigeration or freezing. Specimens are stable for a minimum of 3 days. Longer is better, however frozen does not meet requirements. Specimens must able to be collected in a variety of transport media Specimen types minimum (Nasopharyngeal and Mid-turbinate) Test must be FDA EUA approved Instrument can be used for more than just SARS-CoV-2 Instrument is able to be interfaced with LIS/EHR The Contractor shall provide new testing instruments and all necessary parts, equipment, and software to ensure appropriate operation of instruments herein in accordance with statement of work within 2 weeks of contract award. If additional time is needed contractor needs to specify time frame they would be able to meet. Quotes that fail to include required information, or reject the terms and conditions of the solicitation may be excluded from consideration. Small Business Subcontracting Plan, to include the following at minimum: The Offeror shall prepare and submit a small business subcontracting plan that is in compliance with the FAR clause 52.217-9, - Small Business Subcontracting Plan, Alternate II, as noted in Section I herein. The Offeror shall also discuss its involvement with the DHS Mentor-Prot'g Program and note whether it is a participant (as either a mentor or a prot'g) in that program. DHS and USCG small business subcontracting goals are provided at the following website: https://www.sba.gov/document/support--agency-contracting-goals. USCG encourages the Offeror to make its best effort to match the DHS goals noted in the PDF available at that website. Currently, the DHS small business subcontracting goals are: 42% for small businesses, which includes, 5% for Small Disadvantaged Businesses (SDBs), 5% for Women-Owned Small Businesses (WOSBs), 3% for Service-Disabled Veteran-Owned Small Businesses (SDVOSBs), and 3% for Historically Underutilized Business Zone (HUBZone) Businesses. Past Performance, to include the following at minimum: Provide three (3) relevant past performance of similar efforts of the size and type outlined in this RFQ. The Government will evaluate quoter's relevant past performance by surveying the Past Performance Information Retrieval System (PPIRS) and contracts identified by the quoter. Relevant past performance is previous or current performance of a similar size and scope, and where performance was within three years of offer submission. The USCG reserves the right to utilize past performance information other than the information submitted through PPIRS in conducting the evaluation. Price, to include the following at a minimum: Offerors shall use the price schedule in Attachment 3, Pricing Schedule to indicate the firm fixed price for this requirement in their proposal. O. Evaluation and Award FAR 52.212-2, Evaluation-Commercial Items (Oct 2014) The Government will award a contract resulting from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: The USCG will evaluate whether the Offeror's small business subcontracting plan meets the requirements of FAR clause 52.219-9, - Small Business Subcontracting Plan, Alternate II. The USCG will coordinate its small business subcontracting plan review with the DHS OCPO and will use the DHS Form 700-23, - Subcontracting Plan Review Checklist as a part of its evaluation. Other than small businesses must comply with this requirement to be considered for award. Technical Capability The Government will evaluate each vendor's technical capability to determine if it meets or exceeds each of the requirements listed in Quote Submission paragraph N. ii. 2. Technical Capability. Past Performance The Government will evaluate vendors relevant past performance by surveying the Past Performance Information Retrieval System (PPIRS) and contracts identified by the quote. At the end of the past performance evaluation quotes will receive a summary adjectival rating corresponding to the PPIRS ratings scale. Price The Government will evaluate price reasonableness based on adequate competition and/or a price analysis. Vendors are required to provide a price for 49 Automated Molecular Instruments for the Qualitative Detection of SARS-CoV-2 instruments. Unit price left blank or annotated with something other than a dollar figure will be considered unacceptable and the proposal may be rejected without any further consideration. Evaluation Factors and Basis of Award The Coast Guard will conduct a best value trade-off analysis using Technical Capability, Past Performance, and Price. All non-price evaluation factors, when combined (Technical Capability and Past Performance) are more important than Price. Quotes that take exception to terms and conditions of this RFQ may not be considered for award.