Project Title: Preventative Maintenance and Full Service Contract for (6) Sterilizers/Autoclaves and auxiliary equipment at the FDA Nicholson Lane Research Center (NLRC) Facility. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Parts 12.6 and 13. This announcement constitutes the only solicitation and a written solicitation will not be issued. This combined synopsis/solicitation; NAICS code 339112, Surgical and Medical Instrument Manufacturing identified as RFQ #1068618, is to notify contractors that the government intends to award a Firm Fixed-Price Contract in accordance with FAR Part 13.106 for the following statement of work (SOW), under simplified acquisition procedures. This requirement is unrestricted. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this RFQ. Purpose: The Food and Drug Administration, Center for Biologics Evaluation & Research (CBER), has a need to maintain reliable service of (6) Autoclave/Sterilizer Units and auxiliary equipment used for the sterilization of biological waste, animal food and bedding and research samples and media. Scope of Work: Preventative Maintenance and Full Service to be provided for (4) Amsco Sterilizers, (1) Steris Sterilizer, (1) Consolidated Sterilizer, (1) Steam Filter and (1) Self Contained water tempering unit. All equipment is located within Buildings A and B at the NLRC Facility, 5516 Nicholson Lane, Kensington, MD 20895. Period of Performance: One base year and four one year option periods. Statement of Work: The service shall provide four Preventative Maintenance/Service/Inspections (Quarterly) per year. The Offeror shall provide Full Service emergency response repairs for each piece of equipment/unit/system as listed which shall include all parts, materials, labor and travel time, Monday through Friday, 8:00 am to 4:30 pm for a period of one year with four additional option years, for the Amsco, Steris and Consolidated Autoclaves/Sterilizers, Water Tempering System and steam filter, listed by Building, Room number, model and serial number. Please see the list of equipment for the Sterilizer/Autoclaves and Auxiliary Equipment. All parts shall be included in this contract to include but not limited to door gaskets, backflow preventers, ejectors, check valves, ball valves, gate and globe valves, solenoid valves, safety relief valves, strainers, filters, electronic controller boards, digital display boards and units, micro processors, thermistors, RTDs, (copper, brass, plastic, black iron piping, tubing and fittings), pressure gauges, thermometers, thermostats, transformers, transducers, power supplies, rectifiers, electrical fuses and circuit breakers, switches, data logger/printer assemblies, electric motors, electrical wiring, liquid tight and EMT conduits, armored cables, SO type electrical cords and cord caps, piping and jacket insulation, (pneumatic, electric and hydraulic actuators) All work performed shall be in accordance with the equipment manufacturer’s recommendations and guidelines. The autoclaves/sterilizers shall be maintained and serviced to insure that units will pass testing procedures such as a Bowie-Dick Test, air removal tests, and Biological Indicator tests, to meet time and temperature requirements as per equipment manufacturer’s specifications. The Contractor shall provide a 4 hour call back response time to the requester to acknowledge the call has been received. Contractor shall respond on site to emergency service calls within 24 hours after receiving notification of the service call. The Service Technicians shall have a minimum of two years experience working on the models of the autoclaves/sterilizers and equipment listed. The Service Technicians shall not handle or touch the materials in the sterilizers/autoclaves. This material is only to be handled by the FDA Researchers. Service Technicians shall post an “Out of Order” sign on the autoclaves/sterilizers with an expected date of completion for repairs. All replacement parts shall be new, Original Equipment Manufacturer. If new, OEM parts are not available; replacement parts must meet or exceed factory specifications. The Contractor shall be responsible for the utilities past the last NLRC Building isolation electrical disconnects/switches and valves. Pertaining to the NLRC House Steam Line, the Contractor shall be responsible for the steam piping past the last NLRC isolation valve to the autoclave. In piping arrangements involving a steam condensate drip leg, the Offeror shall be responsible for the piping past the tee to the autoclave, but will not be responsible for the drip leg piping or drip leg condensate trap. This section of piping, valves, and traps shall be maintained by the NLRC Building Maintenance Department. All 6 Autoclaves/Sterilizers are supplied with NLRC House Steam. Due to the critical nature of the Animal Facility production and the quantity of materials requiring sterilization each day, overnight shipping of special ordered parts is required for the sterilizer/autoclave and auxiliary equipment located in B Building, Room 133, Amsco Model 3043, serial 011649003 and the Johnson ½” water tempering valve/unit. The autoclave/sterilizer and supporting auxiliary equipment located in room 133 will require emergency repairs to be completed and the sterilizers/autoclaves available for service within (3) working days after the Offeror has received notification of the service call. Contractor shall inform the Project Officer in writing if this autoclave will be out of service for more than (3) working days for any reason such as, difficulty in obtaining the parts, difficulty in diagnosing and repairing the problem or scheduling issues, with an expected date of completion. All other sterilizers/autoclaves and auxiliary equipment will require emergency repairs to be completed and the sterilizers/autoclaves available for service within (5) working days after the Offeror has received notification of the service call. Contractor shall inform the Project Officer in writing if one of these autoclave will be out of service for more than (5) working days for any reason such as, difficulty in obtaining the parts, difficulty in diagnosing and repairing the problem or scheduling issues, with an expected date of completion. Equipment List: 1. Amsco Unit Model number 3023 Vacuum Sterilizer, Serial Number 012559103, B Building Room Number 107. 2. Amsco Unit Model number 3041, Gravity Sterilizer, Serial Number 010409003, B Building, Room number 107. 3. Amsco Unit Model Number 3043, Gravity Sterilizer, Serial Number 011649003, B Building, Room Number 133. Auxiliary Equipment, (1) Johnson ½” NPT self contained water tempering valve unit, Number JO429. 4. Amsco Unit Model Number 3041, Gravity Sterilizer, Serial Number 012329003, B Building, Room Number 280. 5. Steris Unit Model Number SV120 Sterilizer, Serial Number 013489406, A Building, Suite 110. 6. Consolidated Unit Model Number SR-24A-MC, Serial number 090607, B Building, Room 222. Auxiliary Equipment, (1) Pall Steam Filter, model 1DL11GN16J7, for Consolidated autoclave, B Building Room 222. The Preventative Maintenance shall include the following and shall be in accordance with the equipment manufacturer’s recommendations: Check with the Researcher/end users to determine if there are any particular problems or issues with the units. Check for proper overall working conditions of the units. Check door(s) for proper mechanical operation. Check door gasket and locking mechanism. Lubricate door as per manufacturer’s specifications. Check door safety interlocks. Repair as necessary. Check steam filter for steam leaks and repair as necessary. Replace filter element as required to insure the sterilizer is receiving proper steam flow. Check the Johnson ½” water tempering valve for proper operation and for water leaks. No water should be flowing to the drain when the sterilizer is not in operation. Insure that the tempering unit is tempering the water to a maximum of 140 degrees F. when the sterilizer is in operation. Adjust, calibrate, and repair as needed. Check all solenoid and check valves and rebuild or replace as required. Check sequence and function of all controls for proper operation for each cycle, vacuum/wrapped, gravity/unwrapped and liquid cycles, calibrate, repair or replace parts as needed. Check electric motors for proper operation repair or replace as needed. Check timer/timer controls and calibrate, repair or replace as needed. Check data logger/recorder/printer/indicator lamps and fuses, repair, or replace as needed. Check all electronic controls and controller boards. Repair or replace as necessary. Check and verify all sensors and controls and calibrate or replace to meet factory OEM specifications. Check operation of all pneumatic, electronic, hydraulic actuators, valves and systems, repair or replace as needed. Check for water or steam leaks and repairs as necessary. Check all filters and strainers and clean or replace as required. Check all steam traps and rebuild or replace as required. Check steam pressure relief safety valve as per manufacturer’s guidelines and specifications and ASME regulations. Replace as needed. Check steam regulators and adjust, rebuild or replace as required. Check temperature and pressure controls and repair or replace as needed. Check all electrical connections and electrical safety conditions. Check for air leaks for units with pneumatic controls systems and repair as necessary. Offeror shall provide the Quarterly Preventative Maintenance Schedule to the Project Officer at the beginning of each contract year. Quality Control: The Contractor shall be solely responsible for the quality of their work. All work shall be completed by adhering to all Federal, EPA, State, Local, City, County, NEC, NFPA, ASME and OSHA safety procedures and security rules and regulations. Records: The Contractor shall provide reports of the Preventative Maintenance performed, repairs, and emergency service call repair orders to the Project Officer. The Company Letter Head service invoices will be accepted and given to the Project Officer at the completion of the services. Written notification shall be provided to the Project Officer if the autoclave/sterilizer in B133 will be out of service for more than (3) working days after the Offeror receives notification of the service call, with an explanation of delays and expected date of completion of the repairs. All other Autoclaves/Sterilizers and equipment on the Equipment List will require a written notification to the Project Officer if repairs cannot be completed within (5) working days after the Offeror receives notification of the service call, with an explanation of delays and expected date of completion of repairs. Contractor shall provide the Quarterly Preventative Maintenance Schedule to the Project Officer at the beginning of each contract year. Technical Evaluation Elements: 1. The Offeror shall demonstrate the ability to provide Certified Factory Trained Autoclave/Sterilizer Technicians for the Amsco, Steris and Consolidated Autoclaves/Sterilizers, who will be servicing these Autoclaves/Sterilizers and the auxiliary equipment. 2. The Offeror shall demonstrate the ability to provide Certification data for the calibration of the testing and Measuring instruments and equipment used in the servicing of the autoclaves/sterilizers. 3. The Offeror shall demonstrate the ability to provide all of the parts and materials for the equipment listed and provide new, Original Equipment Manufacturer parts. If new O.E.M. parts are not available; parts that meet or exceed the specifications for new O.E.M. manufacturer parts must be used when performing maintenance and repairs to the said equipment. 4. The Offeror shall demonstrate the ability to provide over night shipping for special ordered parts for the autoclave/sterilizer and the Johnson ½” water tempering valve unit located in the Animal Facility, room B133. 5.) The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. The Government is more concerned with obtaining performance capability superiority rather than lowest overall cost. However, the Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance. Overall cost to the Government may become the ultimate determining factor for award of a contract as quotations become more equal based on the other factors. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to http://www.ccr.gov. You will need your Duns & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to [email protected] no later than Monday February 2, 2010, 12:00pm EST. QUOTATIONS DUE: All quotations are due, via email to: [email protected] no later than 12:00pm, EST on Tuesday February 10, 2010. ANTICIPATED AWARD DATE: The anticipated award date is on or about February 12, 2010; however, all dates in this announcement are subject to change. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items. FAR 52.212-3, Offeror Representations and Certifications Commercial Items, FAR 52.212-4, Contract Terms and Conditions, Commercial Items, FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items, FAR 52.217-8 Option to Extend Services, FAR 52.217-9 Option to Extend the Term of the Contract, FAR 52.232-33 Payment by Electronic Funds Transfer—Central Contractor Registration. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to [email protected] No Phone Calls Will Be Accepted.

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