Preventative Maintenance and Qualification Service for Four (4) Agilent Gas Chromatograph/Mass Spectrometer Systems and One (1) Agilent Gas Chromatograph-Dual Detector System.

1. Solicitation Number: FDA-RFQ-22-1251918 2. Title: Preventative Maintenance and Qualification Service for Four (4) Agilent Gas Chromatograph/Mass Spectrometer Systems and One (1) Agilent Gas Chromatograph-Dual Detector System. 3. Classification Code: 66 4. NAICS Code: 334516 5. Posted Date: May 9th, 2022 6. Response Date: May 13th, 2022, 4:00 p.m. Eastern Time. 7. Description: Disclaimer: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. Notice of Intent to Brand Name Sole Source The proposed contract action is for supplies or services for which the Government is soliciting, only Agilent and authorized service Agilent providers/resellers, under authority of FAR 13.106- 1(b) (1) (i). The brand the Government intends to secure services to is Agilent. This notice of intent is not a request for competitive proposals. However, the Government will consider all proposals received prior to the closing date and time of this solicitation. This acquisition is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through FAR FAC 2022-04 January 30, 2022. For purposes of this acquisition, the associated NAICS code is 334516. The small business size standard is 1000 Employees. Line Item Structure: The following is a list of contract line item number(s) and items, quantities, and units of measure, (including option(s), if applicable): Line Item 0001 – BASE YEAR 17 AUG 2022 – 16 AUG 2023 for Preventative Maintenance and Qualification Service for Four (4) Agilent Gas Chromatograph/Mass Spectrometer Systems and One (1) Agilent Gas Chromatograph-Dual Detector System. Line Item 0002 – OPTION YEAR 1 – 17 AUG 2023 – 16 AUG 2024 for Preventative Maintenance and Qualification Service for Four (4) Agilent Gas Chromatograph/Mass Spectrometer Systems and One (1) Agilent Gas Chromatograph-Dual Detector System. Line Item 0003 – OPTION YEAR 2 – 17 aUG 2024 – 16 AUG 2025 for Preventative Maintenance and Qualification Service for Four (4) Agilent Gas Chromatograph/Mass Spectrometer Systems and One (1) Agilent Gas Chromatograph-Dual Detector System. Specifications/Requirement: The Southeast Tobacco Laboratory (STL) of Center for Tobacco Product (CTP) requires a service and qualification agreement for Four (4) Agilent Gas Chromatograph/Mass Spectrometer Systems and One (1) Agilent Gas Chromatograph-Dual Detector System. The Agilent instruments is an integral component that supports The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) Southeast Tobacco Laboratory (STL) ) by performing sample analyses and analytical support. The instruments are needed to continue to develop methods for identifying and, in some cases, quantifying analytes in tobacco products under FDA regulatory jurisdiction and to establish FDA’s expertise in the analyses of tobacco products. The Contractor shall provide both the Service Agreement and Qualification Service for the system specified in the Statement of Work (SOW). The Contractor shall ensure uninterrupted performance of the system throughout the duration of the contract and, ensure that system operates within the original equipment manufacturer (OEM), Agilent Technologies specifications. Scope The Contractor shall be capable of providing both the Service Agreement and Qualification Service for all systems specified in the SOW to ensure uninterrupted performance within manufacturer’s specification. Minimum Performance Requirements Preventative Maintenance (PM) & Repair: The contractor shall provide at least one (1) preventative maintenance inspection (PMI) service visit during each 12-month period of performance for each instrument. The Technical Point of Contact (TPOC) will contact the Contractor to schedule the PMI. All visits will be scheduled by the TPOC at least seven (7) business days in advance. The Preventative Maintenance Service shall be performed in accordance with the specifications contained in the original equipment manufacturer’s service manual. The PMI shall include all parts, labor, and travel for remedial repair. This includes MS filaments and vacuum pump oil. The contractor shall obtain all new parts required for all repairs and maintenance which meet the original equipment manufacturer’s specifications at no additional cost to the Government. The Contractor shall repair or replace any part or parts which prove to be defective at no additional charge to the government. The Contractor shall make arrangement for the fastest delivery and will resume work upon receipt of parts. The Contractor shall provide documentation of preventative maintenance duties performed. (See Records and Reports section). Minimum Performance Requirements Qualification Service to ISO 9001: The Contractor shall provide Qualification Service after the planned PM and after any other repairs of the system. The Qualification Service shall include Operation Qualification/Instrument Performance Verification (OQ/IPV). The Contractor shall perform at least one (1) annual OQ/IPV verification for the systems that is equal to or exceeds the qualification requirements of the original equipment manufacturer. The OQ/IPV service shall be performed by a qualified engineer. The Contractor shall provide documentation that the system is functioning according to the original equipment manufacturer’s specifications. The OQ/IPV shall include all supplies needed to perform the service. Both the OQ and IPV shall be scheduled at a date approved by the TPOC or Alternate TPOC. The Contractor shall provide the TPOC documentation for temperature verification, calibrations, and an instrument performance run. If at any point during the Qualification Service, the system fails a test, the Contractor shall provide onsite service to remedy the failure and re-execute the Qualification Service to demonstrate to the TPOC that the system passed all the Functional Requirements Specification and the system is operating in accordance with OEM specifications. If parts are needed to re-execute the OQ, the Contractor shall schedule delivery of the necessary parts and perform a return service visit within 48 hours. Service Calls: The Contractor shall respond within two (2) business days after receipt of a service call from the TPOC. The Contractor shall provide unlimited telephone and email access to instrument technical support Monday – Friday between the hours of 9:00 a. m.- 5:00 p.m. EST. All repairs shall result in the system serviced meeting the original equipment manufacturer specifications. All repairs shall use factory, new replacement parts. The Contractor shall perform a diagnostic test and document results and provide a narrative summary demonstrating that the system is meeting the original equipment manufacturer’s specifications Any parts or components removed for replacement shall be returned to the FDA unless the TPOC approves in writing for the parts or components to be disposed. The Contractor shall remove the parts from the site at the time of the service call or provide shipping instructions and return shipping information so that the FDA may return the parts to the Contractor at no additional cost to the Government, no later than three (3) business days after the service visit is completed. The Contractor shall assume all charges and liability for all shipments. Service Conditions: To the maximum extent practicable, service must be rendered on-site at the FDA. The Contractor is responsible for cleanup and removal of all shipping/packing materials at the time of service. Some shipping and packing material cannot be placed in the facility dumpster (e.g. pallets and/or crates) and must be removed by the contractor and at no additional cost to the Government. In the event a part needs to be repaired off-site, the Contractor shall be responsible for all packaging, shipping, and transportation costs as well as liability for the shipment to and from the FDA, 60 8th ST.NE, Atlanta, GA. The Contractor shall be responsible for providing a “Return Authorization Number” or other information authorizing return of the shipment to their facility prior to the shipment. The Contractor shall also provide a shipping account number to pay for the shipment. The Contractor shall only employ tools, parts, instruments, test apparatus, methodologies, techniques, and practices approved for use by Agilent with the Agilent system specified in this contract. Warranty The Contractor shall provide warranty on all labor, replacement parts and components (excluding consumables) of the system for at least a 12-month period. Deliverables The Contractor shall provide the following deliverables: The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. Deliverable: Preventative Maintenance Inspection (PMI) Scheduled Visit Quantity: 1 Delivery Date: Annually during the Period of Performance (POP) at a date approved by the TPOC Deliverable: Operation Qualification/Performance Verification (OQ/PV) Quantity: 1 Delivery Date: Annually during the POP at a date approved by the TPOC or after critical repair Deliverable: Service Reports Quantity: Varies Delivery Date: No Later Than (NLT) 5th workday following the end of each month during any months which work is performed on the system. Place of Performance: Food and Drug Administration Southeast Tobacco Laboratory 60 Eighth Street NE Atlanta, GA 30309 POC: To be identified at time of award Unless otherwise specified, the Contractor shall perform work Monday through Friday (excluding Federal Holidays) between the hours of 8:00 a.m. and 4:30 p.m. EST. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. Workplace is not available on the Government Holidays, or as prescribed by an Executive Order (EO) due to inclement weather. January (New Year’s Day) September (Labor Day) January (Martin Luther King Day) October (Columbus Day) February (President’s Day) November (Veterans Day) May (Memorial Day) November (Thanksgiving Day) June (Juneteenth) December (Christmas Day) July (Independence Day) Instructions to Offeror for Proposal Submission FAR 52.212-1 Instructions to Offerors—Commercial Items (Jun 2020) PROPOSAL SUBMISSION FORMAT: *The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote or proposal. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.* QUOTES DUE: All quotes are due, electronically via email to [email protected] for the RFQ no later than May 13th, 2022, 4:00 p.m. Eastern Time. The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros. FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022) (a) All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm (b) Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov. (c) ----- (1) The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts. (2) Registration emails are sent via email from [email protected]. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to [email protected] or phone (866) 973-3131. (3) The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days. (4) If your company is already registered to use IPP, you will not be required to re-register. (5) If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures. (d) Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable). (e) Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. (1) At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred. - Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category; - Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount; - Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant; - Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed; - Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor; - Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and - Fee – amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable. (f) 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: (1) list of all invoices submitted to date under the subject award, including the following: - invoice number, amount, & date submitted - corresponding payment amount & date received - total amount of all payments received to date under the subject contract or order - and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance. (g) Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate. (h) If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO. (i) Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays. (j) The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort. (k) Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at [email protected]. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue. (END OF CLAUSE) FAR / HHSAR Clauses: I. The provision at 52.212-1, Instructions to Offerors – Commercial DEVIATION 2018-O0018, applies to this acquisition. The following addenda have been attached to this provision: In addition to the requirements set for the in FAR 52.212-1, all offers responding to this solicitation must provide their business size in relation to the NAICS code contained in this solicitation and shall identify any socioeconomic categories to which they belong. II. Evaluation Criteria - The specific evaluation criteria to be used are as follows: Not Applicable – See Brand Name Sole Source Determination. III. Offerors shall include a completed copy of the provision at FAR 52.212-3 (with its Alternate I), Offeror Representations with its offer. IV. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been attached to this clause – Not Applicable V. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) 52.219-28, Post Award Small Business Program Representation (Nov 2020) 52.222-3, Convict Labor (June 2003) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2020) 52.222-21, Prohibition of Segregated Facilities (Apr 2015) 52.222-26, Equal Opportunity (Sept 2016) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) 52.222-50, Combating Trafficking in Persons (Oct 2020) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) 52.204-7 System for Award Management (Oct 2018) 52.204-13 System for Award Management Maintenance (Oct 2018) 52.204-16 Commercial and Government Entity Code Reporting (Aug 2020) 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020) 52.204-24 Representations Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2019) 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment 52.204-26 Covered Telecommunications Equipment or Services-Representation 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 352.239-73 Electronic and Information Technology Accessibility Notice (Dec 2015) 352.239-74 Electronic and Information Technology Accessibility (Dec 2015) 352.232-71 Electronic Submission of Payment Requests (FEB 2022) (a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract. (b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site. (c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures. (d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request. (END OF CLAUSE) VII. This acquisition is rated under the Defense Priorities and Allocations System (DPAS) as N/A VIII. The following notes apply to this announcement: N/A Section 508 Requirements The following standards are applicable for this requirement: Must meet WCAG 2.0 A and AA E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements) E203 Access to Functionality (Appendix A, Application and Scoping Requirements) E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements) E205 Electronic Content (Appendix A, Application and Scoping Requirements) E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements) Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements) 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/accessibility-checklists/index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative. Period of Performance: Base Year – 17 aUG 2022 – 16 AUG 2023 Option year 1 – 17 aUG 2023 – 16 AUG 2024 OPTION YEAR 2 – 17 aUG 2024 – 16 AUG 2025 Set Aside: Small Business Set Aside