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COMBINED SYNOPSIS/SOLICITATION FOR Maintenance for Three (3) ATLHAF Systems Solicitation Number: FDA-24-1272855 This is a combined synopsis/solicitation for commercial services prepared in accordance ... COMBINED SYNOPSIS/SOLICITATION FOR Maintenance for Three (3) ATLHAF Systems Solicitation Number: FDA-24-1272855 This is a combined synopsis/solicitation for commercial services 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-24-1272855. This solicitation is a request for quote (RFQ). The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2023-06, Effective 12/04/2023 The associated North American Industry Classification System (NAICS) Code is 334516 Analytical Laboratory Instrument Manufacturing with a small business size standard of 1,000 employees.. This solicitation is for full and open competition. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. Please submit all quotes with: a) Pricing for all line items Quotes that do not price all line items may be deemed non-responsive. Period for Acceptance of Offers: The quoter agrees to hold the prices firm for 30 calendar days after quote due date. SEE ATTACHED DOCUMENT STATEMENT OF WORK FOR Maintenance for Three (3) ATLHAF Systems 1. BACKGROUND The Food and Drug Administration (FDA) Atlanta Human and Animal Food Laboratory (ATLHAF) comprises Chemistry I, Chemistry II, Microbiology, Nutrition (ACNA), and Tobacco departments that conduct analyses on human & animal foods, ceramics, cosmetics, and tobacco products. These labs use De-Ionized water (DI Water) to perform their tests in accordance with FDA certified methodology which adheres to the guidelines specified in the ISO 17025 accreditation. 2. OBJECTIVE The ATLHAF has three independent De-Ionized (DI) water systems in the Atlanta FDA facility located at 60 8th Street, NE, Atlanta, Georgia 30309. These systems require periodic Mixed Bed DI and Carbon tank exchanges, filter and bulb replacements, periodic Preventative Maintenance and troubleshooting by qualified technical personal. 3. REQUIREMENTS The contractor shall meet the following requirements for the following three systems: ATLHAF requires preventative maintenance, purchase, replacement, and disposal of consumable system components for three independent DI water systems located for the ATLHAF. FDA ATLHAF System A PLACE THE NAME (Evoqua Site #: 0602043479) Reverse Osmosis (RO) DI Water Unit located in Annex II basement Room B12. FDA ATLHAF System B PLACE THE NAME (Evoqua Site #: 0602065699) located in Annex I behind Washroom Room 318. FDA ATLHAF System C PLACE THE NAME (Evoqua Site #: 0602056068) located in Crawford 2nd floor mechanical Room 217. NOTE: Neither System B nor System C has an RO or purified water reservoir tank. A. System A Requirements: ATLHAF has a Reverse Osmosis (RO) feed, DI Water System which generates 6400 gallons of demineralized water per day which is utilized for scientific analyses of food, feed, and other products regulated by the US Food and Drug Administration. This system shall be maintained at the following specified operating parameters: Provide water that is between 3 – 10 megohms-CM at room temp Contains less than 0.1 mg/L of Chlorine Has a microbial purity of less than 100 CFU/ml Individual trace element level of less than 0.05mg/L for Cd, Cr, Cu, Li, Pb and ZN and less than 0.1 mg/L total for all listed elements. To ensure this capability is maintained within the limits specified above, ATLHAF requires that preventative maintenance, replenishment of consumable supplies, and replacement of worn parts be performed throughout the year. The contractor shall provide maintenance to ensure full operational capability in accordance with the specified operating parameters on the following systems/components: 6400 gallon/day RO Water System 14” Simplex Softener Tank 14” Simplex Carbon Tank 12” Simplex Multi-Media Filter Tank 5000 Gallon Storage Reservoir with Level Switch Manual On/Off Switch Control Boxes Recirculation Pump Resistivity Gauge 24gpm UV System 20” 1mic Pre-Filter 30” 5-Round 0.2mic Final Filter 20” 0.2mic Vent Filter 3.6cft Mixed Bed Worker Tank 3.6cft Mixed Bed Polisher Tank B. System B Requirements: DI Water system used to provide demineralized water utilized for scientific analyses of food, feed, and other products regulated by the US Food and Drug Administration. This system shall be maintained to provide water that is between 3 – 10 megohms-CM at room temp. To ensure this capability is maintained within the specified limits above, ATLHAF requires that preventative maintenance, replenish of consumable supplies, and replacement of worn parts be performed the entire year. The contractor shall provide service on the following list of the system’s components that shall be maintained to ensure full operational capability in accordance with the specified operating parameters: SDI React Carbon 3.6 CF Fiberglass Std POT 3 – SDI Mixbed1 3.6 CF UV Sterilizer Lamp – 3084 LM Low 20 “1UM Cartridge No Gasket PP 20” 0.2 UM Cartridge CDE 0 Asym Ploy Pump C. System C Requirements: DI Water system used to provide demineralized water utilized for scientific analyses of food, feed, and other products regulated by the US Food and Drug Administration. This system shall be maintained to provide water that is between 3 – 10 megohms-CM at room temp. To ensure this capability is maintained within the specified limits above, ATLHAF requires that preventative maintenance, replenish of consumable supplies, and replacement of worn parts be performed the entire year. The contractor shall provide service on the following list of the system and its components that shall be maintained to ensure full operational capability in accordance with the specified operating parameters: • SDI React Carbon 3.6 CF Fiberglass Std POT • 2 – SDI Mixbed1 3.6 CF • UV Sterilizer Lamp – 3050 • 20 “1UM Cartridge No Gasket PP • 20” 0.2 UM Cartridge CDE 0 Asym Ploy • Pump 4. SPECIFIC TASKS AND DELIVERABLES The contractor shall provide inspection of the system components listed for each of the three systems on a quarterly basis as follows: A. Systems will be inspected and adjusted, as necessary, by the vendor to maintain peak performance. In addition to inspection(s) and adjustment(s), the vendor is responsible for adhering to a minimum required schedule for various replaceable/consumable components that shall be changed by the vendor in accordance with the schedule provided below, or as deemed necessary, by the vendor in consultation with the ATLHAF system monitor(s) and/or co-monitor(s), to ensure operational performance is maintained within the specifications stated for each system until the next scheduled quarterly maintenance visit. Results of each inspection shall be provided as a written report stating how the components are performing against the defined operational range for each component, as well as, on a system wide level against the resistivity and purity levels listed for each system. i. At the initial Purchase Order (PO) phase, the vendor shall perform a one-time Mechanical Function Check and provide ATLHAF with a written report on the condition of each component, listed for each system as to conformance with normal operating parameters for this system and its component(s), and against the ATLHAF provided Annex 2 DI Water System performance standards. The purpose of the function check is to determine the operational status of the system and identify any problems that could result in future down time so preventative maintenance can be accomplished to avoid future system outages. At a minimum, the Mechanical Function Check will include a review, a report, and recommendation(s) to ATLHAF regarding any maintenance that may be deemed necessary or prudent with regards to the following on all systems: i. UV intensity ii. efficiency iii. Test SDI Water Quality Specs-Within 1 Meg iv. Perform Pump Function Check v. Perform Carbon Function Check vi. Perform MMF Function Check vii. Perform UV Function Check viii. Document Site, Record Readings and Deliver to Customer ix. Per quarter, on System A Perform Softener Function Check x. Test Feed Water Chemistry (TDS, Chlorine, Hardness, Temperature) xi. Test RO Feed Water Chemistry (TDS, Chlorine, Hardness, Temperature xii. Verify and Test RO Performance (Product Quality, Product Flow, Reject %, Reject Flow xiii. Verify Tank Level Switch and Low-Level Pump Switch are Operational xiv. Perform Softener Function Check ii. Per Quarter for DI-Water Systems A, B and C, the vendor will perform the following: i. Test SDI Water Quality Specs-Within 1 Meg ii. Perform Pump Function Check iii. Perform Carbon Function Check iv. Perform MMF Function Check v. Perform UV Function Check vi. Document Site findings, Record Readings and Deliver to Customer iii. Per quarter, the vendor shall provide and install the following parts/components on: i. On System A: 1. 1 - 3.6cft Mixed Bed SDI Worker Tank* 2. 1 - 3.6cft Mixed Bed SDI Polisher Tank* 3. * Extra tanks, if required, for purchase by Govt IMPAC at contract pricing. 4. If required, vent pumps to remove air. ii. On Systems B and C: 1. 1 – 20” 1UM CART No Gasket PP, per system iv. Biannually, the vendor shall provide and install the following: i . On System A: 1. 1 - MP2SL 24gpm UV bulb ii. On Systems B: 1. 1 - 3084LM Low UV Sterilizer Bulb iii. On Systems B and C: 1. 1 – 20” 0.2UM CDE 10 ASYM POLYSUL 2. 1 - 3.6CF SDI MIXBD Fiberglass STD POT 3. 1 – 3.6 CF SDI Reactive Carbon Fiberglass STD POT v. Annually, the contractor shall provide and install the following: i. On system A: 1. 1- 20” 1 mic Pre-filter 2. 1 - 30” 5-Round 0.2 mic Final Filter for SS Housing 3. 1- 20” 0.2 mic Vent Filter vi. The contractor shall test Silica annually on Systems B and C. In addition, Lamp UV Sterilizer 3050 (System C), UV Lamp Disposal/Reclaim Fee Large Lamp, Insp & Rec Service DI Performance Data, PM Contract Recurring – Parts and Labor The contractor shall provide additional requirements for the DIW Systems (System A, System B, and System C): A. Contractor shall notify the lab at least 24 hours prior to scheduled site visits to perform routine maintenance and/or repairs. B. Contractor shall remove all disposables such as bulbs, filters plus Resin, Carbon, and Media tanks after each replacement. C. Although not funded under this PO, ATLHAF requires a predetermined cost per hour for service calls to deal with outages occurrences during the following time frames: i. During normal business hours, 8:00 AM to 4:30 PM, Monday – Friday (excluding federal holidays) ii. After Normal Business hours, Monday – Friday (excluding federal holidays) iii. Weekends (Saturday/Sunday) anytime of the day 5. INSPECTION AND ACCEPTANCE CRITERIA Inspection and acceptance shall be in accordance with the base clause 52.212-4(a). The Contracting Officer’s Representative (COR) is responsible for the inspection and acceptance of the services under this requirement. Acceptance Any operational system or component parameter found to be outside those specified for that system, or otherwise stated by the original equipment manufacturer, shall be immediately reported to the ATLHAF system monitor(s), and/or assistant monitor(s), along with any recommended corrective actions that may be required to return or maintain the system within the required operational parameters stated by ATLHAF above. No corrective action or component replacement that will incur additional costs outside the scope of this Purchase Order shall be implemented by the vendor without the express approval of the Contracting Officer of Record (COR) for this Purchase Order. To deal with deficiencies or malfunctions discovered during the stated routine inspections or at other times when reported by the ATLHAF System Monitor(s), ATLHAF requires the ability to purchase service labor and parts separate from this PO, via the small purchase card process, when they are needed in numbers greater than those stated in the requirements section (e.g. paragraphs 5 – 8) of this PO when/if required to ensure the continuous operational capability of, or to return the RO DI System in Annex 2 to operational status, as the result of a malfunction and/or consumption rates that exceed those projected by SRL and stated in this PO. Purchase of said service labor and parts shall be at the same cost as they are quoted under this PO. ORDER ADMINISTRATION 7. CONTRACT TYPE This is a firm fixed price purchase order 8. PERIOD OF PERFORMANCE The period of performance is for a base year with two (2) one-year options. The anticipated dates are: Base Year – January 22, 2024 to January 21, 2025. Option Year 1 - January 22, 2025 to January 21, 2026 Option Year 2 - January 22, 2026 to January 21, 2027 Unless otherwise specified, the Contractor shall perform work Monday through Friday (excluding Federal Holidays) between the hours of 8:00 a.m. and 4:30 p.m. EST. Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day. Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) due to inclement weather. Government Holidays: January (New Year’s Day) September (Labor Day) January (Martin Luther King Day) October (Columbus Day) February (President’s Day) November (Veterans Day) May (Memorial Day) November (Thanksgiving Day) June (Juneteenth) December (Christmas Day) July (Independence Day) 9. PLACE OF PERFORMANCE Food and Drug Administration Atlanta Human and Animal Laboratory 60 Eighth Street NE Atlanta, GA 30309 10. GOVERNMENT POINTS OF CONTACT Contract Specialist Elena Tatarov U.S. Food and Drug Administration Office of Acquisitions and Grants Services 4041 Powder Mill Road, STE 400 Beltsville, MD 20705 Phone: 301-796-7379 Email: elena.tatarov@fda.hhs.gov Contracting Officer’s Representative (COR) TBD – provided at time of award PLEASE SEE THE ATTACHEMENT FOR ALL REQUIREMENTS