Statement of Work - Liquid Chromatograp.pdf

Statement of Work

Liquid Chromatograph Purchase for PNL’s Sciex 4500 Mass Spectrometer

Background

During 2020, the FDA mycotoxin analysis program standardization and harmonization committee implemented a new analytical approach to monitor mycotoxins in human and animal food.

Mycotoxin analysis is concerned with determination of potentially harmful mold-growth products in a wide variety of food products. The analytical method involves concurrent analysis of twelve mold-growth products. One of the new analytical criteria for this analysis requires all FDA laboratories performing this analysis to have the same or comparable model of liquid chromatographic/tandem mass spectrometer (LCMS). This requirement is CRITICAL since LCMS having different internal technological characteristics and structures that produce significantly different results.

Objectives

PNL desires to use the requested liquid chromatograph equipment to interface with an existing Sciex QTRAP 4500 mass spectrometric system for use in the FDA mycotoxin monitoring program. This purchase will effectively double the laboratory’s capacity to analyze mycotoxin samples using the prescribed FDA Chemical Analytical Method C-003.01.

Scope The Pacific Northwest Laboratory expects to utilize the requested equipment to bring an existing Sciex QTRAP 4500mass spectrometric system to analyze human and animal food using FDA Chemical Analytical Method C-003.01.

Tasks

Minimum Technical Specifications

Critical performance specifications include components that meet or exceed the specifications and capabilities of the Sciex Exion LC AD system.

Critical Requirements

• Ultra High-Performance Liquid Chromatography (UHPLC) system must interface and communicate with each individual module and with the government owned Sciex 4500 QTRAP mass spectrometer. The UHPLC system must include the following modules:

Controller module

▪ Communicate and interface with all modules within the UHPLC system

▪ Communicate and interface with Sciex 4500 QTRAP mass spectrometer

▪ Communicate and interface with Sciex OS and Analyst software

Degasser module

▪ Capable of degassing up to 5 lines

▪ Leak Detection

Solvent bottle tray capable of holding at least 4 bottles of mobile phase

SOW

Pump modules

▪ Two (2) double plunger pump modules

▪ Stable flow ranging from:

• 0.0001 to 3.0000 mL/min. (max pressure 1300 bar)

• 3.0001 to 5.0000 mL/min. (max pressure 800 bar)

• 5.0001 to 10.0000 mL/min. (max pressure 220 bar)

▪ Flow rate precision <0.06% RSD

▪ Flow rate accuracy ±1%

▪ Automatic piston rinsing function

▪ Flow controller valve to select solvent lines from at least 2 pumping units

▪ 20µL binary micro mixer module

▪ Leak detection

Autosampler module

▪ Injection volume: 0.1 to 50µL

▪ Maximum carryover: 0.0015%

▪ Maximum allowable pressure: 1300 bar

▪ Sample vial cooling range: 4°C to 40°C

▪ Capable of holding at least 100 (1.5mL-2mL) vials

▪ Capable of using up to 4 rinse solutions after sample injection

▪ Leak detection

Column oven module

▪ Stable temperature range: room temperature to 150°C

▪ Temperature control precision: ±0.05°C

▪ Capable of holding two (2) columns (15cm max) at the same time

▪ Leak detection

2 position/6 port column switching valve that is rated for up to 1300 bar pressure and mounted to the UHPLC system

Electrical: all modules must be compatible with 110V AC, 50/60 Hz outlet(s)

Includes at least 5 solvent bottles, 5 solid caps, 5 vented caps and solvent lines

Includes any additional accessories required to operate the UHPLC system, i.e.

tubing, fittings, cables, etc.

• Includes no computer or printer as the interface control of this UHPLC system will be through the government owned Sciex 4500 QTRAP mass spectrometer’s computer and its installed Sciex OS and Analyst software.

• Includes instrument set up, installation, and connection to government owned Sciex 4500 QTRAP mass spectrometer is required.

Trade and Service Specifications

1. The instruments must be a newly manufactured unit, not used and refurbished or previously used for demonstration.

2. Delivered Place Unloaded (DPU) to include inside delivery and clean-up of area after installation.

3. The entire system must be warranted for parts and labor for 12 months from the date of formal government acceptance. The vendor must also be capable of servicing the instrument through the covered warranty period. The system must 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, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair, and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have

(verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts.

The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts.

4. Instrument operators shall have access to a technical representative call center at no additional charge, for technical assistance and troubleshooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

5. Preventative maintenance (PM) visit shall be included for the base contract year. This visit shall be inclusive of all parts, labors, travel, consumables, and supplies which are necessary to complete the OEM’s suggested PM protocol. Service engineers which perform this service shall trained by the OEM.

6. Sufficient familiarization training for 3-5 users per delivery 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 any consumables to be used during training.

7. The Contractor shall provide installation qualification with an employee who can provide proof of installation qualification/Operation qualification (IQ/OQ) certification.

Records and Reports

The Contractor shall, commensurate with the completion of 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. In addition, the Contractor shall provide monthly reports to the FDA PROJECT

OFFICER and Contract Specialist, not later that the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed).

Deliverables:

Description Quantity Delivery Date

Liquid Chromatograph (LC) configured to work with Sciex 4500. 1 Within 60 days of award.

Installation and setup of LC 1 Within 30 days of delivery.

Familiarization Training – up to 5 users 1

Within two weeks after installation and setup

Year One PM Service 1 6/30/2022

Service Reports Varies Not later that the 5th workday following the completion of the service

Shipping Destination:

US Food & Drug Administration – PNL ATTN: To be determined at the time of the award 22201 23rd Dr SE Bothell, WA 98021

The Contractor shall provide the Contracting Officer’s Representative (COR), Office of Regulatory Support (ORS) Subject Matter Expert (SME), and the Division of Field Administration (DFA) administrative staff with at least one (1) week’s written notice prior to delivery. Contractor shall coordinate with Delivery Order Technical Point of Contact when scheduling delivery date. When vendor representatives/shipping company arrive on site to deliver the items, they will need to provide valid U.S. photo identification to check-in with the on-site Security Guards to enter the premises.

Delivery shall occur (Monday – Friday) between the times of 8:00 AM – 4:00 PM, excluding Federal holidays or Federal Closures. Federal holidays are listed below, and specific dates can be found at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay:

New Year’s Day Martin Luther King, Jr. Day Presidents Day Memorial Day

Independence Day Labor Day Columbus Day Veterans Day

Thanksgiving Day Christmas Day

If vendor representatives arrive on site to deliver / install equipment, they will need to provide proper U.S. photo identification to check-in with the Federal Protective Service (FPS) Security Guards in order to enter the building. The vendor representatives will receive an “Escort Required” temporary badge, which must always be worn in the building and will remain escorted by lab personnel during their visit. If vendors need to enter the laboratory, safety glasses must be worn. When their work is complete, the vendor representatives will provide the lab personnel a work order or service receipt detailing the requirements of the visit. The vendor representatives will check-out with the same FPS Security Guards, turning in their temporary badge. Tobacco, of any form, and e-cigarettes are not permitted on Federal Property, in Federal Buildings or parking lots.

Government-Furnished Property, Material, Equipment, or Information (GFP, GFM, GFE, or

GFI)

The Government will not provide any equipment to the Contractor.

Security

No confidential, sensitive or PII information are generated by this equipment. No confidential, sensitive or PII information are generated or stored on the scientific computer.

This component contains no Information Technology hardware or software. It will connect to an existing system that meets all government security requirements.

Travel

Contractor shall be responsible for all travel necessary to complete the requirements of this award.

Special Material Requirements

There are no special material requirements associated with this purchase.

Other Unique Requirements

Beyond the instrument’s characteristics, there are no additional unique requirements associated with this purchase.

Place of Performance

The requested equipment will operate in the Chemistry Section of the FDA Pacific Northwest Laboratory, 22201 23rd Drive SE, Bothell, WA 98021

Period of Performance

The Period of Performance begins the date of contract award execution and continues for one year (or longer depending on how long the OEM offered warranty period is) from the date of formal government acceptance.