Maintenance/Repair Ultra Wave, Ultra Clave Digestive Systems

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 synopsis, NAICS code 811219, identified as REQ 1242001 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. This is a firm fixed price requirement. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516. This procurement will be for a small business set aside. Vendors must be registered in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.sam.gov 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. Background/Purpose: The Kansas City Laboratory requires Preventative Maintenance and potential repair services for two Milestone UltraWAVE systems, SNs: 14040375 and 11060065, and one Milestone UltraCLAVE Microwave Digestive System, SN: 1408171. Whenever the instrument has been out of service it has been detrimental to normal operations as sample analysis was delayed until the instrument was repaired. This specialized equipment is essential to support the program requirements for the elemental analysis of toxic and nutritional elements in food and dietary supplements for both the FDA Total Diet surveillance program and for regulatory samples. This equipment is presently subjected to a consistently heavy workload and it will continue to be utilized for sample digestion for the foreseeable future. Due to recent changes implemented in the sample collection schedule and procedures of the FDA Total Diet surveillance program, OEM service contract is essential for this equipment to prevent any work interruption. The most recent Preventative Maintenance was performed by Milestone on 12/2020. Scope: Purchase of a full-service contract (Preventative Maintenance and Repair Services) for Milestone UltraWAVE and UltraCLAVE Microwave Digestive Systems (SNs: 14040375, 11060065 and 1408171) including all necessary components such as the chiller, nitrogen compressor and automatic gas loading module. Specifications: PERFORMANCE REQUIREMENTS : The service contract must provide one annual Preventive Maintenance per system (SNs: 14040375, 11060065 and 1408171) in accordance with the ISO 17025 standard, as well as unlimited on-site repair service visits with a maximum 72-hour on-site response time (for issues that cannot be resolved remotely via telephone or Internet). The technician must be qualified on the specific system they are working on, and able to produce all required supporting documentation to demonstrate these qualifications in accordance with the ISO 17025 standard. The service contract must include one annual Preventative Maintenance per system on all accompanied components supporting the operation of the microwave digestion systems in accordance with the ISO 17025 standard, as well as unlimited on-site repair service visits with a maximum 72-hour on-site response time (for issues that cannot be resolved remotely via telephone or Internet). The technician must be qualified on the system they are working on and able to produce all required supporting documentation to demonstrate these qualifications in accordance with the ISO 17025 standard. Examples of the accompanied components include, but are not limited to, an LW100E1N nitrogen compressor (equivalent or upgraded version), a LabTech H150-1000 Water Recirculating Chiller (equivalent or upgraded version) and Automatic Gas-Loading Modules (AGM), which are fully compatible with the Milestone UltraWAVE and UltraCLAVE Microwave Digestive System (SNs: 14040375, 11060065 and 1408171). Calibration and system performance evaluations are to be performed after repair or replacement of parts to include all necessary components. A report detailing the exact specifications the system is required to meet, the actual measurements of those parameters produced, and the vendor’s conclusion of the services rendered shall be produced to the customer within 72 hours of the completion of service(s). All travel and labor costs are to be covered under the service contract. All consumables necessary for the operation of the instruments shall be covered under the contract. There shall be no exclusions to replacement consumables. This should include replacement of tubing or parts with observable acid exposure, replacement of appropriate chiller fluid, etc. All repairs and/or consumables made or replaced shall be documented within the report furnished to the customer within 72 hours of the completion of service(s). Firmware/software updates related to the maintenance of the instrument’s performance shall be included. All firmware/software upgrades/updates shall be documented within the report furnished to the customer within 72 hours of the completion of service(s). At least one annual onsite preventative maintenance visit shall be included annually with the service contract. The preventative maintenance parts and applicable kits related thereto shall be included in the service contract at no extra cost. The preventative maintenance shall include all replacement(s) of consumables in accordance with the Original Equipment Manufacturer (OEM) maintenance schedule, including but not limited to replacement of the chiller water, O-rings, acid-impacted connection lines, etc. The Contractor shall provide instrumental technical support to isolate and resolve hardware problems via telephone and e-mail access, Mondays – Fridays (excluding Federal Holidays) between the hours of 7:00 AM – 5:00 PM (local time at Contractor’s place of business) and shall begin working on a solution to the problem within 8 business hours of contact for assistance. (e.g., telephone-based, email-based). All maintenance and repair activities (including warranty work) shall be accomplished in accordance with Original Equipment Manufacturer (OEM) specifications using OEM parts. Any part no longer supported by the OEM shall be upgraded or replaced with the comparable, supported OEM part. Costs of replacement/upgrade shall be covered under the service contract. Deliverables: Deliverable Quantity Delivery Date Annual Preventative Maintenance 1 Within 15 days of contact for scheduling Repair Service As needed Within 72 hours of contact Field Service Report Upon completion of any service performed by Contractor. 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 COR, not later that the 5th workday 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). Place of Performance Place of Performance US Food & Drug Administration – Kansas City Laboratory Attn: POC to be identified at time of award. 10749 W. 84th Terr. Lenexa KS, 66214 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. Please propose for each period. BASE YEAR - 2021—2022, OPTION YEAR 1 – 2022 – 2023 OPTION YEAR 2 – 2023 – 2024 OPTION YEAR 3 – 2024 – 2025 The base Period of Performance will start on award date. 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 31, 2021 to the attention of Julia Savage, [email protected] . Offerors shall ensure the RFQ number is visible in the header of the email. FAX QUOTES SHALL NOT BE ACCEPTED.