SOW_LCMS SOW.pdf

STATEMENT OF WORK

PROJECT TITLE

One (1) Liquid Chromatography with Mass Spectrometer (LC-MS) system

BACKGROUND

The National Forensic Chemistry Center (NFCC) in the Office of the Commissioner/Office of Chief Scientist/Office of Specialty Laboratories and Enforcement Support (OC/OCS/OSLES) requires the purchase of one (1) hybrid quadrupole/linear ion trap mass spectrometer system to be used in conjunction with one (1) ultra-high performance liquid chromatograph (LC-MS/MS).

The addition of this system will enhance capabilities for the detection and quantitation of drugs of abuse, such as synthetic opioids, the results of which would support criminal and regulatory investigations involving foods, drugs, dietary supplements, medical products, tobacco products and vape products, as well as the analysis of products received at the international mail facilities (IMFs) and Express Courier Hubs (ECHs).

GENERAL DUTIES / DESCRIPTION OF WORK

The National Forensic Chemistry Center (OC/OCS/OSLES/NFCC) requires one (1) hybrid quadrupole/linear ion trap mass spectrometer with one (1) ultra-high performance liquid chromatograph (LC-MS/MS). The system offers data-dependent acquisition (DDA), data-independent acquisition (DIA), and MSn acquisition through use of the hybrid quadrupole/linear ion trap and will enhance capabilities for both targeted and non-targeted identification and quantitation of small molecules, particularly approved and counterfeit drugs, opioids, designer drug isomers and analogs, synthetic cannabinoids, misbranded/adulterated dietary supplements, and designer steroids in support of investigations involving foods, drugs, dietary supplements, medical products, tobacco products and vape products.

MINIMUM SALIENT CHARACTERISTICS

All of the following are minimum requirements. Equivalent requirements that differ from these minimum requirements shall be justified by the proposing vendor and evaluated by the NFCC prior to purchase.

General

• The system shall include a LC-MS that is capable of detecting narcotics, including fentanyl, fentanyl analogs, and other narcotics and be capable of analyzing powders and liquids.

• The delivered systems should include one set of installation and service manuals; and preloaded computer software required to operate and control the LC-MS.

• The system shall be delivered with all necessary supplies and accessories required for installation and start-up.

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

• The system must include at least a one (1) year warranty, which 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, software updates and notifications.

Liquid Chromatograph (LC):

• The LC shall be equipped with a binary pump with high pressure mixing and solvent degasser.

• The LC shall have a flow rate range of 0.001-5 mL/min and be adjustable in 1 µL/min increments.

• The LC shall be equipped with a pressure range of 50-600 bar (i.e., pressure may go lower than 50 bar or higher than 600 bar, but must cover this range at a minimum)

• The LC shall have a flow rate accuracy of ± 0.1% and a flow rate precision of ≤

0.05% RSD.

• The LC shall be operable at a pH range of 2-12.

• The LC autosampler thermostat shall be controlled with a temperature range of at least 4-40 °C.

• The LC column compartment thermostat shall be controlled with a temperature range of 20-80 °C (i.e., the temperature range may go lower than 20 °C or higher than 100 °C, but must cover this range at a minimum).

• Mass Spectrometer (MS):Ionization source salient characteristics

• The ionization source shall be an atmospheric pressure ionization (API) source that includes the following features:

(1) x, y, and z probe positioning

(2) Heated electrospray ionization (HESI) probe

(3) Interchangeable atmospheric pressure chemical ionization (APCI) functionality

(4) Integrated calibrant source for automated mass calibration

• The instrument shall have at least one or more linear ion trap mass analyzers capable of the following:

(1) Scan range m/z 50-1500 or greater (i.e., scan range may go lower than m/z 50 or higher than m/z 1500, but must cover this range at a minimum)

(2) Resonant collision induced dissociation (rCID) or tandem-in-time MSn, with helium trapping/collision gas

(3) MSn precursor isolation, rCID fragmentation, and full-scan product ion spectra acquisition

(4) Maximum MS3 rate > 25 Hz

(5) Capable of data-dependent MSn, where n > 3.

• The instrument shall be capable of multiplexing multiple precursor ions

• The instrument shall be capable of polarity switching

• The instrument shall include a syringe pump for tuning and a 6-port valve (or equivalent) for LC-MS experiments

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 COR and/or COR designee, not later that the fifth workday 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

Deliverable Quantity Delivery Date

1 LC-MS/MS 1 No later than 90 days after award

Familiarization Training - up to 6 users

Within two weeks after Government acceptance of instrument

PLACE OF PERFOMANCE

One complete LC-MS/MS instrument to be shipped to and located at the following laboratory:

1) National Forensic Chemistry Center / Food and Drug Administration 6751 Steger Dr.

Cincinnati, OH 45237 POC: Lisa Lorenz

(301) 837-4451 lisa.lorenz@fda.hhs.gov

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. Instrument to be delivered no later than 30 days after contract award.

mailto:lisa.lorenz@fda.hhs.gov