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. The solicitation number is FDA-RFQ-24Q1277571. This requirement is issued as Request for Quote (RFQ). The solicitation is issued as a Full and Open competition. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC-2024-05, Effective 05/22/2024. The associated North American Industry Classification System (NAICS) Code is 811310 with a small business size standard of $12.5 million . The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the requirements herein. BACKGROUND The steam sterilizers are essential equipment utilized in the digestion process as part of the extraneous filth analysis. Samples that the filth group analyzes in conjunction with the autoclave are import samples with short time frames or consumer complaint samples that take high priority. The steam sterilizers are also being utilized in the microbiology branch for the sterilization of prepared media, reagents, and supplies as well as for the sterilization of bio-hazardous waste produced in the lab. They are essential for the branches and any downtime due to service-related problems impact the labs. OBJECTIVE The purpose of this Statement of Work is to provide a detailed list of deliverables expected from the procurement of comprehensive preventive maintenance to be performed on the following four Steris Autoclaves (steam sterilizer): Autoclaves Serial Numbers 3AV-ADVPRO SN# 102313 SR-24E-ADVPRO SN# 102413 AMSCO Century SV-120 SN# 033531459 REQUIREMENTS Contractor shall response on-site within two business days or less (for issues that cannot be solved remotely). All work shall be performed Monday-Friday 8:30 a.m.-5:00 p.m. Contractor shall provide at least one preventative maintenance (PM) visit per contract year. This visit shall be inclusive of all parts, labor, travel, consumables, and supplies to complete the most recent OEM’s PM protocol. The contractor shall ensure the service engineers who perform the services are trained by the OEM. Contractor shall cover all costs associated with parts, labor, travel. Contractor shall provide maintenance on printer, valves, and connections for leaks, verify door operations, test chamber flood switch, and clean chamber drain strainer. Contractor shall provide verification test cycle at the conclusion of visit. Contractor shall in complete the following during the annual period of the maintenance contract: Annual OEM door maintenance, verify chamber temperature calibration, verify pressure calibration, inspect chamber, and jacket gauges, verify operation of door switch, rebuild chamber trap, jacket trap, and seat, replace safety valves, replace chamber air filter cartridge. Run vacuum leak test, clean steam strainer screen, rebuild steam solenoid valves, clean water strainer screen, rebuild chamber drain components. Contractor shall provide inspection of check values, flow control values, and pressure relief valves. Trade and Service Specifications Any replacement components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. Any replacement components and/or equipment shall be warranted for parts and labor for a minimum of 12 months from date of formal government acceptance. The warranty must include unlimited telephone/e-mail support for questions regarding operation. Contractor shall schedule any service visits at least 48 hours in advance by contacting TPOC/COR. Field Service Report The Contractor shall provide a field service report for each service call (inclusive of warranty service), 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. INSPECTION/ACCEPTANCE CRITERIA Inspection and acceptance shall be in accordance with the base clause 52.212-4(a). Contracting officer’s representative (COR) is responsible for the inspection and acceptance of the deliverables for this requirement. CONTRACT TYPE This is firm fixed price. PERIOD OF PERFORMANCE Description: Period: 3AV-ADVPRO Base Year: 9/01/24-8/31/25 SR-24E-ADVPRO AMSCO Century SV-120 3AV-ADVPRO Option Year 1: 9/01/25-8/31/26 SR-24E-ADVPRO AMSCO Century SV-120 3AV-ADVPRO Option Year 2: 9/01/25-8/31/27 SR-24E-ADVPRO AMSCO Century SV-120 The period of performance (POP) is for a base year with four (2) option years. PLACE OF DELIVERY AND PERFORMANCE The place of performance will be at the Government site indicated below: U.S. Food and Drug administration Atlanta Human and Animal Feed Laboratory (ATL-HAF) 60 8th Street NE Atlanta, GA 30309 HOURS OF OPERATION Work/Deliveries shall typically be performed/delivered during normal business hours (typically between 8AM and 5PM Eastern) Mondays through Fridays. FEDERAL HOLIDAYS The Government will not require support for the Federal Holidays listed below. Specific dates can be found on https://www.opm.gov/. New Year's Day Birthday of Martin Luther King, Jr. Washington’s Birthday Memorial Day Juneteenth National Independence Day Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day GOVERNMENT CLOSURES Government operating statuses for offices nationwide can be found on https://www.opm.gov/. Aside from Federal holidays, the contractor shall contact the COR or Contracting Officer to determine work status in the event of Government closures. If a contractor staff has been approved to work at an alternate work site, the Government anticipates that the contractor staff will continue to perform their tasks as assigned at the order level. In the event of inclement weather, contractor staff that work on-site at a Federal facility shall be responsible for checking the operating status. If the facility is closed and the contractor staff is telework ready, the contractor staff may be required to work at the direction of the COR or CO. GOVERNMENT POINTS OF CONTACT Contract Specialist Warren Jackson U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Road, STE 400 Beltsville, MD 20705 Phone: 301-796-7376 Email:
[email protected] Contracting Officer’s Representative/Technical Point of Contact (TPOC) T o be determine after award. All responsible sources may submit a quote, which if timely received, shall be considered. The quote and any questions submitted shall reference the solicitation number and name. Quote Due Date & Time: 3 July 24; 12:00 pm EST Quoters that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. Point(s) of Contacts: Warren Jackson at
[email protected]