Attachment 1 - Statement of Work - Leco FP928.pdf

STATEMENT OF WORK

Combustion Protein Analyzer Brand

Name (Leco FP928) – Sole Source

Background

The Food and Drug Administration (FDA) Atlanta Human and Animal Food Laboratory (ATLHAFL)

Nutrient Analysis Branch (NAB) require replacement of an existing obsolete Nitrogen Determinator system used to analyze infant formula, medical foods, food, dietary and feed samples for the analysis of protein utilizing the Dumas method. The NAB performs nutrient analysis on food products, animal feed and dietary supplements. This includes infant formula and medical foods which have stricter guidelines because they may serve as a sole source of nutrition for the consumer. The system must maintain compliance with cGMP/cGLP/ISO/IEC 17025-2017, ISO 9001:2008, and 21 CFR part 11 standards as required under current laboratory accreditation.

Purpose/Scope

The current nitrogen determinator system has become obsolete and the manufacturer cannot provide service or replacement parts. The purpose of this acquisition is to replace the existing nitrogen determinator system with a new, fully serviceable unit to ensure uninterrupted protein analysis of high-priority infant formula and medical food samples.

The Contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this

Statement of Work (SOW), specifically:

▪ System A: One (1) FP928 model Boom Mounted Touchscreen/Autoloader PC Macro Nitrogen

Determinator (Brand Name: Leco FP928)

▪ Part B: A Gold Maintenance Agreement for one (1) base period plus four (4) option years.

Minimum Required Technical/Performance Specifications

The instrument shall meet the following minimum requirements:

I. System A

• Shall be a Model FP928 Boom Mounted Touchscreen with Autoloader PC Macro Nitrogen

Determinator (Leco FP928, brand name/sole source), meeting all specifications outlined in this SOW.

• This is a brand-name (sole-source) requirement for the Leco FP928; “or equal” substitutes will not be evaluated. See the sole-source justification and market research.

• The system shall comply with the approved methods of analysis: ISO, AOAC, AACC, AOCS, and

ASBC.

• Shall include Horizontal ceramic furnace design with exclusive oxygen environment ensuring complete oxidation of macro samples.

• Maximum operating temperature of 1450°C (minimum requirement)

• Shall accommodate large, open and reusable ceramic sample boats that facilitate the handling and combustion of macro samples ranging from 1 to 3 grams.

• Shall have sample ash retention in boat for post-analysis removal, eliminating furnace tube maintenance requirements.

• Thermal conductivity cell shall support the flexibility of using helium or argon as a carrier gas without hardware change.

• Shall have rapid analysis times that are low-cost with instrument designs with reagent-free furnaces.

• Shall have long lifetimes with the model FP928 featuring a combustion gas aliquot system that provides extended and consistent reagent lifetime including a 4000-sample reduction tube reagent lifetime.

• Shall have a dual loop aliquot doser provided with the flexibility to optimize methods based upon sample element concentration (low/high) or analysis cost and uptime.

• The instrument shall have the Cornerstone software on a Boom-Mounted Touchscreen which enables the operator to have a more efficient workflow (operator-centered design).

• Shall have extended reagent lifetimes which contribute to a low cost-per-analysis

• Shall have expanded furnace efficiency and reliability with a reagent-free design – with a reagent-free, high-efficiency furnace with intelligent control that expands the heating element and ceramic lifetime.

• Shall have a thermoelectric cooler which eliminates the use of chemicals desiccant reagents for the removal of combustion gas moisture in the Nitrogen/Protein model.

• Shall have 100-sample position autoloader for sequential and non-sequential analysis

• Shall have a rapid cycle-time of 5 minutes

• Shall have an ergonomic, operator-centered design with boom-mounted touch-screen interface which introduces all operations on one screen.

• Shall have a SmartLine remote diagnostics that can allow for plots of ambience or multiple ambiences at the same time to optimize time frame.

• Shall have a SmartLine that includes advance Leak Check Diagnostics to help the operator diagnose a problem or find a potential leak in the system.

• Shall have the Cornerstone software that can perform advanced diagnostics, monitor the instrument and furnace, perform calibrations divided into four parts: Analysis, Diagnostics, Settings and

Instrument – for simplified navigation and organization.

• Shall have advance interactive diagnostic features that include a digital on-board manual, maintenance animations, photo-illustrations, and screen capture that provides direction needed.

• Shall have live screens that will show color-coded tubing inside the instrument, and an automated system will check for verification of operational systems.

• Shall have easy access to all reagent tubes and common maintenance areas for simplified maintenance

• Shall be reliable with a knowledgeable, state-of-the-art technical service (experienced application chemists to assist in method development).

• Shall provide a global and regional service network with regional support centers dedicated to providing service and support.

• The determination of protein is conducted in accordance with Official AOAC Method 990.03 and

LIB 4635, specifically applicable to infant formula analysis. These methods require nitrogen determination via combustion using a Leco nitrogen/protein analyzer. To support this analytical capability, we are seeking to procure the Series FP928 model with boom-mounted touchscreen and autoloader PC macro system, designed for accurate and efficient nitrogen and protein determination through combustion.

Installation Requirements

• The Contractor shall provide on-site installation and setup—including delivery, set-up, installation, clean-up of installation area and training—within 2 weeks of receipt of equipment.

• The contractor shall provide installation qualification (IQ) and Operational Qualification (OQ) performed by a certified employee who can provide proof of IQ/OQ certification.

Initial Training

• The Contractor shall provide comprehensive operator training at the time of installation for up to four (4) users. Onsite location will be provided at time of installation or shortly thereafter (within 30 days), such that operators may independently operate the instrument and with increased familiarity and proficiency.

• The training shall include manuals and consumables for use during training.

• Training Location: FDA/ATLHAFL Nutrient Analysis Branch (NAB), 1777 Hardee Avenue SW

Atlanta, GA 30310, Room 2333, Protein Laboratory.

Trade and Service Specifications

• The instruments shall be newly manufactured units, not used and refurbished or previously used for demonstrations. The Contractor shall provide routine customer service and technical support to be available from the vendor during its lifecycle.

• The system shall include at least a one (1) year warranty and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, computer, monitor, factory-certified replacement parts, engineer labor and travel costs. This requirement does not obligate the Government to purchase an extended warranty. However, the entire system(s) must be covered on a manufacturer warranty for parts and labor for a minimum of 12 months to start after the completion of installation, training, and formal government acceptance, and include preventative maintenance. The vendor must also be capable of servicing the instrument through an extended warranty service (See Item II Options).

• Instrument operators shall have access to a technical representative call center, for technical assistance and troubleshooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

• At least one preventative maintenance (PM) visit shall be included per contract year. This visit shall be inclusive of all parts, labor, travel, consumables, and supplies which are necessary to complete the OEM’s suggested PM protocol. Trained OEM engineers shall perform service.

• System shall be delivered no later than 30 days after award.

Warranty period

The Contractor shall provide a comprehensive manufacturer's warranty covering all parts, labor, and travel for a minimum period of twelve (12) months from the date of final acceptance.

The warranty period shall run concurrently with the first year of the maintenance agreement.

Minimum Required Maintenance Agreement Specifications

The contractor shall perform the following minimum tasks:

II. Gold Maintenance Agreement:

• Provide a timeline for instrument approximate date of delivery, installation, qualification.

• Provide “One KIT PMA Gold Maintenance Plan” required for first preventative maintenance visit.

• Perform one (1) preventative regular preventive maintenance call annually from the effective date of the

Contract. The contractor shall document the final state of the instrument at each of these calls.

• Perform two (2) emergency maintenance visits from the effective date of the Contract. The contractor shall document the final state of the instrument at each of these calls

• Inspect the equipment at each visit and make the necessary adjustments or repairs.

• Emergency maintenance shall begin within forty-eight hours of a maintenance request.

• Maintenance shall be provided by maintenance engineers who are trained and certified by the original manufacturer of this instrument. Maintenance engineers shall have access to the manufacturer's latest technical developments, repair procedures, application updates, and diagnostic software and planned maintenance procedures.

• The contractor shall perform the adjustment and alignments to original factory specification or better, to meet the manufacturer’s performance specifications.

• The contractor shall perform software upgrades to the most current version, to meet the manufacturer’s performance specifications.

• All software updates to the scientific equipment and/or software and related installation of such instrument updates and /or software during the Agreement Term.

• Upon the preventative maintenance on-site visit, the contractor shall assess the scientific equipment and determine if the repairs needed to the scientific equipment are covered under the maintenance agreement.

If the repairs are not covered under the maintenance agreement and are deemed necessary to complete the preventative maintenance, the contractor shall submit a quote to the Government for review, and approval or negotiation, which shall include travel costs, parts costs and labor costs.

• Warranty on parts and labor for any repairs completed during the maintenance period is for the term of the contract.

• Unlimited telephone support during regular business hours, 8:00 AM-5:00 PM ET. for instrument support and applications at no additional charge

• The contractor shall perform all non-emergency work during FDA’s regular business hours on regular business days.

• Unlimited use of Smartline remote diagnostic tool.

III. Maintenance Calls:

• The Contractor shall respond within two (2) business days after receipt of a maintenance call from the TPOC.

• The Contractor shall provide unlimited telephone and email access to instrument technical support

Monday – Friday between the hours of 8-5 p.m. EST.

• All repairs shall result in system maintenance meeting the original equipment manufacturer specifications. All repairs shall use factory, new replacement parts.

• The Contractor shall perform a diagnostic test and document results and provide a narrative summary demonstrating that the system is meeting the original equipment manufacturer’s specifications.

Any parts or components removed for replacement shall be returned to the FDA unless the

TPOC approves in writing for the parts or components to be disposed of. The Contractor shall remove all replaced parts from the site at the time of the maintenance call. If immediate removal is not possible, the Contractor shall provide prepaid shipping instructions and documentation within three (3) business days of the visit, ensuring the return of parts is at no cost to the

Government.

• The Contractor shall assume all charges and liability for all shipments.

IV. Gold Maintenance Plan Conditions

• To the maximum extent practicable, maintenance shall be rendered on-site at the FDA.

• The Contractor is responsible for cleanup and removal of all shipping/packing materials at the time of maintenance. Some shipping and packing material cannot be placed in the facility dumpster (e.g. pallets and/or crates) and shall be removed by the contractor and at no additional cost to the Government.

• In the event a part needs to be repaired off-site, the Contractor shall be responsible for all packaging, shipping, and transportation costs as well as liability for the shipment to and from the U.S. Food and Drug Administration (FDA), 1777 Hardee Avenue SW, Atlanta, GA 30310.

• The Contractor shall be responsible for providing a “Return Authorization Number” or other information authorizing return of the shipment to their facility prior to the shipment. The

Contractor shall also provide a shipping account number to pay for the shipment.

Security

The Contractor shall check in with Security at front desk and be escorted by FDA personnel.

Records and Reports

The Contractor shall, commensurate with the completion of each maintenance call (inclusive of warranty maintenance), provide the end-user of the equipment with a copy of a field maintenance report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being maintenance/repaired and detailing the reason for the maintenance call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the maintenance, the name(s) and contact information of the technician who performed the repair/maintenance, and for information purposes, the on-site hours expended and parts/components replaced.

Deliverables

The Contractor shall be responsible for delivery, installation, IQ/OQ of one (1) FP928 model Boom Mounted

Touchscreen/Autoloader PC Macro Nitrogen Determinator instrument (Brand Name: Leco FP928) (System A).

Table 1. Deliverables / Schedule

Deliverable Quantity Delivery Date

System A 1 30 days upon award

Installation 1 Within 2 weeks of receipt of equipment

Training/Familiarization 1 At the time of installation or shortly thereafter (within

30 days) – Up to four users

Preventative Maintenance Inspection

(PMI) Scheduled Visit

Annually during the Period of Performance (POP) at a date approved by the TPOC

Operation Qualification/Performance 1 Annually during the POP at a date approved by the

TPOC or after critical

Maintenance Reports

Varies No Later Than (NLT) 5th workday following the end of each month during every month in which work is performed on the system.

Shipping Destinations

System A (quantity 1) to be shipped to the following laboratory:

FDA/Atlanta Human and Animal Food Laboratory (ATLHAFL)

Nutrient Analysis Branch (NAB)

1777 Hardee Avenue SW

Atlanta, GA 30310

POC: To be identified at the time of award.

Period of Performance

System A: The period of performance begins on the contract award execution date. Equipment includes a one-year warranty starting from the date of formal government acceptance.

Part B (Maintenance Agreement): The maintenance agreement consists of a base period of one year, plus four one-year option periods. This covers Preventative Maintenance and Operational Qualification Maintenance.

The anticipated Period of Performance is as follows:

Base Period: 08/1/2026 – 07/31/2027

Option Year 1: 08/1/2027 – 07/31/2028

Option Year 2: 08/1/2028 – 07/31/2029

Option Year 3: 08/1/2029 – 07/31/2030

Option Year 4: 08/1/2030 – 07/31/2031