Service/Repair Agreement and Operation Qualification Service

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6. This announcement constitutes the only solicitation and a written solicitation will not be issued. “Brand Name or Equal product only”. The following FAR Clause applies: Clause 52.211-6 - Brand Name or Equal (AUG 1999) This requirement is “Subject to the Availability of Funds” The Following FAR Clause applies: AVAILABILITY OF FUNDS (52.232-18) (APR 1984) This synopsis, NAICS code 811219, identified as REQ 1240727 is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following specifications, under the simplified acquisition procedures. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the beta.sam.gov website for the release of any amendments to this solicitation. Hard copies will only be provided to individuals eligible under the Americans with Disabilities Act and Rehabilitation Act upon request. Specifications: Potential vendors must demonstrate the ability to provide The Center for Tobacco Product (CTP) Southeast Tobacco Laboratory (STL) service and qualification service agreement for a Leco Pegaus 4D GCxGC TOFMS System S/N: 4144 (LECO Corporation, Inc.) “Brand Name or Equal.” Preventative Maintenance - Repair Service The Contractor shall provide full coverage of parts, labor and travel for all repairs within any restrictions stated in the warranty. The Contractor shall provide at least one (1) preventative maintenance inspection (PMI) for the instrument during the one (1) year period of performances. The PMI shall be scheduled through communication with the FDA Project Officer or Alternate. The PM shall include all consumables, parts, labor and travel for remedial repair. 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 within 72 business hours (3 days) or a mutually agreed upon timeframe. All parts replaced shall be new replacement parts which meet the original manufacturer’s specifications (Leco Pegasus 4D GCxGC TOFMS System, S/N: 4144 (LECO Corporation, Inc.) The Contractor Officer Representative (COR) shall contact the Contractor to schedule a mutually acceptable date and time for the preventive maintenance visit. All visits must be scheduled at least 48 hours in advance with the COR. Documentation of preventative maintenance duties performed must be provided. (See Records and Reports section). Qualification Service The Qualification service for the system shall include operation qualification/performance verification (OQ/PV) to be performed after the planned preventative maintenance (PM) and in the event of a critical repair. The Contractor shall perform at least one (1) annual OQ/PV verification for the system that is equal to or exceeds the qualification requirements of the manufacturer The OQ/PV service shall be performed by a qualified engineer and must provide documentation that the instrument is functioning according to the manufacturer’s specifications. (Leco Pegasus 4D GCxGC TOFMS System, S/N: 4144 (LECO Corporation, Inc.) The OQ/PV must include all supplies needed to perform the service. Both OQ/PV shall be scheduled through communication with the FDA Project Officer or Alternate FDA Project Officer. The Contractor shall provide documentation calibrations and an instrument performance run. If at any point during the qualification and the instrument fails a test, the Contractor shall provide onsite service to remedy the failure and re-execute the qualification and must demonstrate to the COR that the instrument passed the test. If parts are needed to re-execute the OQ, the Contractor shall schedule delivery of the necessary parts and a return service visit shall occur within 48 hours. Service Calls The Contractor shall respond onsite within 72 hours after receipt of a service call. Contractor must wear a mask at all times while performing services at the FDA facility. The Contractor shall provide unlimited telephone and email access to instrument technical support. All repairs must result in the instrument(s) serviced meeting the manufacturer specifications and must use factory new replacement parts (Leco Pegasus 4D GCxGC TOFMS System S/N: 4144, LECO Corporation, Inc.) Any parts or components removed for replacement shall become the property of the Contractor unless otherwise agreed to by the parties. The Contractor shall remove the parts from the site at the time of the service call or provide shipping instructions and return shipping information that the FDA may return the parts to the Contractor at the Contractor’s cost within 3 days after the service visit is completed. The Contractor shall assume all charges and liability for all shipments. Removal of any packaging materials shall be the responsibility of the Contractor. The Contractor shall perform a diagnostic test results or narrative summary demonstrating that the instrument is meeting the manufacturer’s specifications. (Leco Pegasus 4D GCxGC TOFMS System, S/N: 4144 (LECO Corporation, Inc.) Service Conditions To the maximum extent practicable, service must be rendered on-site at the FDA. 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 the original manufacturer with the Pegasus 4D instrument specified in this contract. (Leco Pegasus 4D GCxGC TOFMS System, S/N: 4144, LECO Corporation, Inc.) The Contractor shall remove all packaging materials from the site at the time of service. Records and Reports 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. In addition, the Contractor shall provide monthly reports to the FDA Project Officer and Contract Specialist, not later than the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month during months that work is performed. Deliverables Deliverable Quantity Delivery Date PMA Scheduled Visit 1 Annually during the POP Operation Qualification 1 Annually during the POP or after critical repair Service Reports Varies NLT 5th work day following the end of each month during any months which work is performed on the instrument. Warranty All labor, replacement parts and components (excluding consumables) shall be warrantied for at least a 12-month period. Place of Performance Food and Drug Administration Southeast Tobacco Laboratory 60 Eighth Street NE Atlanta, GA 30309 POC: To be identified at the time of award The Contractor shall contact the Government POC at least 48 hours prior to delivery or service. Unless otherwise specified, deliveries and installation shall occur at the Place of Performance specified above, Monday through Friday (excluding Federal Holidays between the hours of 8:00 a.m. and 5:00 p.m. EST. Period of Performance The period of performance shall be for a base period of one year with four one-year option periods for Preventative Maintenance and Operation Qualification Services. BASE YEAR - 06/16/2021 – 06/15/2022 OPTION YEAR 1 – 06/16/2022 – 06/15/2023 OPTION YEAR 2 – 06/16/2023 – 06/15/2024 OPTION YEAR 3 – 06/16/2024 – 06/15/2025 The Government will award a contract resulting from this solicitation to the responsible quoter as a fixed‐price contract on the lowest price technically acceptable (LPTA) evaluation method. Award will be made on the basis of the lowest evaluated price meeting or exceeding the non‐cost factor (technical conformance to the requirements of the solicitation). The Quoter’s initial quotation shall contain the Quoter’s best terms from a price standpoint. Failure to demonstrate meeting any of the requirements will result in a rating of technically unacceptable and will not be considered for award. FAR provisions can be found on the following website: http://Acquisition.gov The following provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Items; 52.225-2 Buy American Certificate; 52.212-4 Contract Terms and Conditions-Commercial Items; 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items including subparagraphs: 52.222-3, Convict Labor 52.222-19, Child Labor-Cooperation with Authorities and Remedies 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Affirmative Action for Workers with Disabilities 52.222-50, Combating Trafficking in Persons 52.225-1, Buy American Act--Supplies 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. In order to facilitate the award process, ALL quotes shall include a statement regarding the terms and conditions herein. Additionally, all quotes shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are Registered in SAM under NAICS code; 811219 delivery date (delivery date is of the utmost importance); business size; and payment terms. Delivery shall be to FDA. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email to [email protected] and be received by 5:00 PM (1700) on May 20, 2021 to the attention of Mary Rose A. Nicol, [email protected] . Offerors shall ensure the RFQ number is visible in the header of the email. ALL QUESTIONS REGARDING THIS SYNOPSIS/SOLICIATION MUST BE SUBMITTED IN WRITING NO LATER THAN 5:00 PM (1630) EST ON May 17, 2021. FAX QUOTES SHALL NOT BE ACCEPTED.