Preventive Maintenance Plan for Media Clave and Media Jet Systems

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-24Q1277446. This requirement is issued as Request for Quote. The solicitation is issued as Full and Open Competition.

The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC-2024-05, Effective 04/22/2024 The associated North American Industry Classification System (NAICS) Code is 541990 The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the requirements herein.

A list of line-item number(s) and items, quantities, and units of measure (including option(s), as applicable) can be found in sections vi and vii of the solicitation. Description of Requirement and vii. Order Administration Information BACKGROUND The Atlanta Food and Feed Laboratory is a full-service facility capable of performing a broad spectrum of analyses. The Microbiological Sciences Branch is the largest of the three branches that comprise ATLHAF. The Microbiological Sciences Branch analyses approximately 2,500 – 3,000 samples a year which covers a broad spectrum of samples to include:

food samples, cosmetics, animal foods, infant formula, pharmaceuticals to name a few. Media preparation prepares and autoclaves media for approximately 75,000 plates and dispenses approximately 45,000 tubes in various sizes annually. Basic microbiology lab tasks such as media preparation and dispensing, sample preparation and temperature monitoring are highly repetitive, time-intensive and tedious activities that could be completed easily by automated equipment.

OBJECTIVE The purpose of this acquisition is to request a service agreement plan for the Media Clave (S/N 14060569) Media Jet system (S/N 10314663) to include (4) option years that meets the following service requirements. REQUIREMENTS Minimum Required Service Specifications The service plan shall include full coverage of all parts, labor time, travel time and expenses during contract period. The replacement parts shall be new, not used and refurbished or previously used for demonstration.

The service shall be covered during normal business hours and include recommended preventative maintenance. The service plan shall include all software upgrades. The service plan shall cover telephone support during normal business hours (8:00 AM – 5:00 PM, Monday – Friday) All service shall be performed in accordance with the specifications contained in the manufacturer’s service manual. The service agreement shall cover all parts and labor for 12 months.

The vendor must be capable of servicing the instrument through the additional option years. This requirement does not obligate the Government to exercise the option years. Preventative Maintenance for the Media Clave shall include:

Check of the lid gasket Check security of the lid locking device Check of temperature and calibration Replacement of sterile air filter cartridge Check for wearing of vessel locking mechanism and magnetic stir bar support. Clean tubing and metallic filter cartridges Leak test tubing Check all gaskets and connections. Test water level sensor to ensure functionality and leak resistance. Check printer. Perform electronic control test. Test for integrity of electronic connections Run a complete cycle test. Preventative Maintenance for the Media Jet System shall include:

Clean the unit and perform an optical control of the frame and modules. Analyze logbook entries. Check all carousel positions to identify any crooked rods. Clean and check the function of gripper jaw, replace silicone rubber. Clean, check and grease the flap bearing and check the tension of the spring. Clean, check the condition and grease the feeder and stacker pistons, clean and grease the spindle and replace the sealing If necessary.

Check belt for abrasion and Initial tension, if necessary, readjust Clean and check function of the reflection light sensors. Check the electrical grounding connection and connectors on main and Interface board. Validate the feeder and stacker calibration values and readjust. Validate the rotor and carrousel calibration values and readjust. Check the function of the cooler module, the display and the keypad buttons. Clean and check UV-lamp, replace If working hours exceed 1000h. Run a general performance test.

Records and Reports The Contractor shall complete 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.

INSPECTION/ACCEPTANCE CRITERIA Inspection and acceptance shall be in accordance with the base clause 52.212-4(a). The technical point of contact (TPOC)/contracting officer’s representative] is responsible for the inspection and acceptance of the deliverables for this requirement. CONTRACT TYPE This is firm fixed price. PERIOD OF PERFORMANCE The period of performance (POP) is for a base year with four (4) option years. PLACE OF DELIVERY AND PERFORMANCE The place of performance will be at the Government site(s) indicated below:

Food and Drug Administration 60 Eighth Street NE Atlanta, GA 30309 POC: Provide at Award 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. DELIVERABLES AND DELIVERY SCHEDULE The Contractor shall deliver all items to the technical point of contact (TPOC)/contracting officer’s representative] as set forth below:

Description Qty Unit Delivery Schedule/ Period of Performance Base: Preventive Maintenance Plan for Media Clave SN:14060569; Media Jet System SN:10314663 1 EA 9/16/2024-9/15/2025 Option Year 1: Preventive Maintenance Plan for Media Clave SN:14060569; Media Jet System SN:10314663 1 EA 9/16/2025-9/15/2026 Option Year 2: Preventive Maintenance Plan for Media Clave SN:14060569; Media Jet System SN:10314663 1 EA 9/16/2026-9/15/2027 Option Year 3: Preventive Maintenance Plan for Media Clave SN:14060569; Media Jet System SN:10314663 1 EA 9/16/2027-9/15/2028 Option Year 4: Preventive Maintenance Plan for Media Clave SN:14060569; Media Jet System SN:10314663 1EA 9/16/2028-9/15/2029 9. 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: Brian.Wodzisz@fda.hhs.gov Contracting Officer’s Representative/Technical Point of Contact (TPOC) TBD – provided at time of award.