Environmental Sensors Performance Maintenance and Verification for San Juan Laboratory

i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) 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. In accordance with FAR 13.106-1(b) this is a sole source requirement. ii) The solicitation number is 18-223-SOL-1199498. iii) The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-97, Effective 24 Jan 2018 iv) The associated North American Industry Classification System (NAICS) Code is 811219 - Other Electronic and Precision Equipment Repair and Maintenance v) The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. Please submit all quotes to be valid until September 30, 2018. CLINS: Description Period Preferred Period of Performance 0001 VAL/SERV B (44) pts Base Period 7/30/18 - 7/29/19 002 VAL/SERV B (44) pts Base Period 7/30/15-7/29/19 0003 VAL/SERV B (44) pts Option Year 1 7/30/19 - 7/29/20 0004 VAL/SERV B (44) pts Option Year 1 7/30/19-07/29/20 0005 VAL/SERV B (44) pts Option Year 2 7/30/20 - 7/29/21 0006 VAL/SERV B (44) pts Option Year 2 7/30/20-7/29/21 0007 VAL/SERV B (44) pts Option Year 3 7/30/21 - 7/29/22 0008 VAL/SERV B (44) pts Option Year 3 7/30/21-7/29/22 vi) Description A. BACKGROUND The U.S. FDA, San Juan Laboratory in the Office of Regulatory Science, Office of Medical Products, Tobacco, and Specialty Laboratory Operations, located at 466 Fernandez Juncos Ave., San Juan, Puerto Rico 00901, needs annual performance maintenance and calibration verification for an existing Rees Temperature Monitoring Control System. This includes verification for laboratory safety hood sensors, batteries, supporting network connection cables, remote panels, and wireless transmitters. The existing system and software require annual maintenance, calibration and validation to comply with cGMP/cGLP, ISO/IEC 17025-2005, and ISO 9001:2008 standards. The Rees system is an environmental monitoring system used to monitor real-time readings for critical environmental parameters such as temperature, humidity, voltage, oxygen, and air flow. Rees Scientific Corp. is the manufacturer of the system hardware and software already installed at FDA facilities in San Juan, Puerto Rico. The system utilizes both proprietary software and hardware and maintenance/new installations within the system requires intimate knowledge of both. Any upgrades of software must also be performed by Rees Scientific. FDA maintains a full service contract with Rees Scientific that would otherwise be voided if work were to be performed on the system by a third party. B. REQUIREMENTS/DELIVERABLES Satisfactory performance of this contract shall be deemed to occur upon performance of services described above or and upon acceptance by the Contracting Officer, or the COR, of these products/services. Deliveries required by the contractor shall be made F.O.B. destination within 35 days from receipt of the award of order to the address listed below: Food and Drug Administration San Juan Laboratory 466 Fernández Juncos Ave. San Juan, PR. 00901-3223 POC: To be identified at time of award vii) The provision at 52.212-1, Instructions to Offerors-Commercial Items (Jan 2017), applies to this acquisition with the following addenda to the provision. Period for Acceptance of Offers: The offeror agrees to hold the prices firm through August 30, 2018. viii) The provision at 52.212-2, Evaluation-Commercial Items (Oct 2014), is applicable to this requirement. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible offeror whose proposal meets the specifications listed under v) and vi) 3 of this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable. A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. ix) The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2017), applies to this acquisition. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website located a. x) The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (Jan 2017), applies to this acquisition with the following addenda: Invoice Submission: FDA Three-Way Match Invoicing Procedures A. The contractor shall submit all invoices to: U.S. FOOD AND DRUG ADMINISTRATION Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor MAIL HUB 2145 Silver Spring, MD 20993-0002 301-827-3742 [email protected] *** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR. The COR is (TBD) B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (i) Name and address of the contractor; (ii) Invoice date and invoice number; (iii) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements); (iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; (c) any other supporting information necessary to clarify questionable expenditures; (d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed; (v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading; (vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30); (vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (viii) Name, title, and phone number of person to notify in event of defective invoice; (ix) Taxpayer Identification Number (TIN); (x) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT); (xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award; (xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes: (a) list of all invoices submitted to date under the subject award, including the following: (1) invoice number, amount, & date submitted (2) corresponding payment amount & date received (b) total amount of all payments received to date under the subject contract or order (c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance; (xiii) Any other information or documentation required by the award. C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing. D. Questions regarding invoice payments should be directed to the FDA Payment Office at the e-mail address provided above in Section A. xi) The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (Jan 2018), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: • 52.222-21 Prohibition of Segregated Facilities (Apr 2015) • 52.222-26 Equal Opportunity (Sept 2016) (E.O. 11246) • 52.222-35 Equal Opportunity for Veterans (Jul 2015) (38 U.S.C. 4212) • 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793) • 52.222-50 Combating Trafficking in Person (Mar 2015) • 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513) • 52.232-33 Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332) xii) Additional contract requirement(s) or terms and conditions FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) FAR 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 any time prior to the expiration of the current period of performance; provided that the Government gives the Contractor a preliminary written notice of its intent to extend 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 2 years. (End of clause) The following HHSAR clauses apply and can be obtained at the following website: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html By reference: (a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the "Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards" set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the "Access Board") in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards. (b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense. (c) The Section 508 accessibility standards applicable to this contract are: o 1194.21 systems o 1194.22 web based o 1194.31 functional requirements o 1194.41 documentation, support (d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website: (http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense. (e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense. (End of clause) It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. xiii) All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number 18-223-SOL-1199498. The quotes are due by email to the point of contact listed below on or before July 3, 2018 by 10:00 am ET. xiv) Point of Contact: Aaron Fisher at (301) 796-6762 or email at [email protected].